Quick answers
- What is Nitroglycerin used for?
- The FDA-approved label (Nitrolingual, Independence Pharmaceuticals, LLC, May 13, 2024) says: “Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nitroglycerin have a boxed warning?
- The label we quote has no boxed warning, but 2 of 64 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Nitroglycerin?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 14, 2026). Ask your pharmacist about alternatives.
- Has Nitroglycerin been recalled?
- FDA enforcement reports list 6 recalls of products of this medicine; the newest started July 24, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Nitroglycerin?
- 37 companies list prescription products of Nitroglycerin in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, Mylan Pharmaceuticals Inc. and Ingenus Pharmaceuticals, LLC.
What Nitroglycerin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
— FDA label: Nitrolingual, Independence Pharmaceuticals, LLC, effective May 13, 2024. Read the full label on DailyMed →
The FDA has 64 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
2 of 64 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Patch · Ointment · Spray · Injection · Injection, solution |
|---|---|
| Route | Sublingual · Transdermal · Oral · Intravenous · Rectal · Topical |
| Prescription products | 100 in the FDA NDC Directory |
| Brand names | Nitrostat, Nitro-Dur, Nitroglycerin in Dextrose, Nitroglycerin Transdermal Infusion System, Nitroglycerin Lingual, Rectiv, Nitrolingual, Nitro-Bid |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| nitroglycerin 0.1 mg/h patch | Generic | $0.4942 per patch |
| nitroglycerin 0.2 mg/h patch | Generic | $0.5931 per patch |
| nitroglycerin 0.3 mg tablet | Generic | $0.0652 per tablet |
| nitroglycerin 0.4 mg tablet | Generic | $0.0824–$0.1297 per tablet 17 packages, lowest to highest |
| nitroglycerin 0.4 mg/h patch | Generic | $0.7260 per patch |
| nitroglycerin 0.4% ointment | Generic | $7.32 per gram |
| nitroglycerin 0.4% ointment | Brand: Rectiv | $20.59 per gram |
| nitroglycerin 0.6 mg tablet | Generic | $0.0829 per tablet |
| nitroglycerin 0.6 mg/h patch | Generic | $0.9547 per patch |
| nitroglycerin 120 mg patch | Generic | $0.9547 per patch |
| nitroglycerin 2% ointment | Brand: Nitro-Bid | $1.23–$2.42 per gram 3 packages, lowest to highest |
| nitroglycerin 20 mg patch | Generic | $0.4942 per patch |
| nitroglycerin 40 mg patch | Generic | $0.5931 per patch |
| nitroglycerin 400 ug spray | Generic | $14.56–$24.01 per gram 5 packages, lowest to highest |
| nitroglycerin 60 mg patch | Brand: Nitro-Dur | $50.50 per patch |
| nitroglycerin 80 mg patch | Generic | $0.7260 per patch |
NADAC list of November 4, 2026; these prices took effect between August 19, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- HF Acquisition Co LLC, DBA HealthFirst10 products
- Mylan Pharmaceuticals Inc.7 products
- Ingenus Pharmaceuticals, LLC6 products
- Medical Purchasing Solutions, LLC5 products
- Dr. Reddy's Laboratories Inc.4 products
- Proficient Rx LP4 products
- A-S Medication Solutions4 products
- Viatris Specialty LLC3 products
- Aurobindo Pharma Limited3 products
- Golden State Medical Supply, Inc.3 products
- Baxter Healthcare Company3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Remedyrepack Inc.3 products
- Lifestar Pharma LLC3 products
- Advagen Pharma Ltd3 products
- Solco Healthcare U.S., LLC3 products
- NuCare Pharmaceuticals, Inc.3 products
- Dr.Reddys Laboratories Inc3 products
- Natco Pharma USA LLC3 products
- Redpharm Drug2 products
- ProPharma Distribution2 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Sportpharm LLC2 products
- Henry Schein, Inc.2 products
- Encube Ethicals, Inc.2 products
- Bryant Ranch Prepack1 product
- TruPharma, LLC1 product
- American Regent, Inc.1 product
- Allergan, Inc.1 product
- Prasco Laboratories1 product
- Cosette Pharmaceuticals, Inc.1 product
- Independence Pharmaceuticals, LLC1 product
- NorthStar RxLLC1 product
- Allegis Pharmaceuticals, LLC1 product
- Medical Purchasing Solutions, LL1 product
- Solaris Pharma Corporation1 product
- Savage Laboratories a division of Fougera Pharmaceuticals, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA018705 NITROLINGUAL, NITROLINGUAL PUMPSPRAY | Pohl Boskamp | October 31, 1985 | 19, latest July 30, 2018 2018: Labeling · 2016: Labeling · 2016: Manufacturing (CMC) |
| NDA019970 NITROGLYCERIN IN DEXTROSE 5% | Baxter Hlthcare | December 29, 1989 | 16, latest August 22, 2016 2016: Labeling · 2015: Manufacturing (CMC) · 2014: Labeling |
| NDA020145 NITRO-DUR | Uspharma | December 10, 1985 | 16, latest January 8, 2016 2016: Manufacturing (CMC) · 2014: Labeling · 2005: Labeling |
| NDA021134 NITROSTAT | Viatris | May 1, 2000 | 6, latest January 24, 2018 2018: Labeling · 2017: Labeling · 2016: Labeling |
| NDA021359 RECTIV | Abbvie | June 21, 2011 | 1, latest July 23, 2024 2024: Labeling |
Generic approvals (17)
- ANDA087355Fougera Pharms Inc · May 28, 1981
- ANDA072034Am Regent · May 24, 1988
- ANDA074559Mylan Technologies · August 30, 1996
- ANDA091496Padagis Israel · September 20, 2013
- ANDA208191DR Reddys · August 26, 2016
- ANDA206391Glenmark Speclt · September 19, 2017
- ANDA211604Natco · April 30, 2019
- ANDA209779Rubicon Research · May 3, 2021
- ANDA217879Aurobindo Pharma · October 26, 2023
- ANDA217970Mankind Pharma · December 5, 2023
- ANDA216103Cosette Pharms Nc · February 16, 2024
- ANDA218583Pharmobedient · October 15, 2024
- ANDA212222Tp Anda Holdings · November 29, 2024
- ANDA216452Encube · December 16, 2024
- ANDA218235Encube · April 15, 2025
- ANDA218756Amvika · December 18, 2025
- ANDA214565Padagis Israel · July 6, 2026
Shortage status
To be discontinued · updated April 14, 2026 · first posted April 14, 2026
| Product | Rectiv, Ointment, 0.4% (NDC 58914-301-80) |
|---|---|
| Company | AbbVie Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 24, 2026 · Class II · Ongoing · D-0791-2026
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967. — American Regent, Inc.
-
March 13, 2025 · Class II · Ongoing · D-0324-2025
CGMP Deviations
Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0331-2025
CGMP Deviations
Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430 — Glenmark Pharmaceuticals Inc., USA
-
December 27, 2021 · Class II · Terminated · D-0372-2022
Defective Delivery System
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02 — Padagis US LLC
-
March 15, 2021 · Class II · Terminated · D-0419-2021
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 3524 — Cardinal Health Inc.
-
November 18, 2013 · Class I · Terminated · D-1057-2014
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass containers, Baxter Healthcare Corp., Deerfield, IL --- NDC 0338-1049-02 — Baxter Healthcare Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 198038, 198039, 198040, 207273, 207331, 207346, 207361, 237205, 242946, 312004 … (+10) |
|---|---|
| SPL set ID of the quoted label | d19b5f51-ca85-48d6-9ccd-8ae26249cdc3 |
| FDA labels (SPL) | 64 |
| FDA applications | NDA018705, NDA019970, NDA020145, NDA021134, NDA021359, 17 ANDA |
| Active ingredients (FDA) | NITROGLYCERIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nitrolingual, Independence Pharmaceuticals, LLC, effective May 13, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →