Quick answers
- What is Tramadol hydrochloride used for?
- The FDA-approved label (ConZip, Vertical Pharmaceuticals, LLC, December 29, 2025) says: “CONZIP is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tramadol hydrochloride have a boxed warning?
- Yes. The FDA label for ConZip has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tramadol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tramadol hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 19, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Tramadol hydrochloride?
- 38 companies list prescription products of Tramadol hydrochloride in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and Asclemed USA, Inc..
What Tramadol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
CONZIP is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …
— FDA label: ConZip, Vertical Pharmaceuticals, LLC, effective December 29, 2025. Read the full label on DailyMed →
The FDA has 93 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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CONZIP
. Read it on the full label →
89 of 93 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Tablet, coated · Tablet, film coated · Tablet · Tablet, film coated, extended release · Capsule, extended release · Capsule · Solution |
|---|---|
| Route | Oral |
| Prescription products | 127 in the FDA NDC Directory |
| Brand names | Conzip |
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 |
|---|---|---|
| tramadol hydrochloride 100 mg capsule | Generic | $7.71 per capsule |
| tramadol hydrochloride 100 mg tablet | Generic | $1.10 per tablet |
| tramadol hydrochloride 100 mg tablet, coated | Generic | $1.10 per tablet |
| tramadol hydrochloride 100 mg tablet, extended release | Generic | $0.8901 per tablet |
| tramadol hydrochloride 100 mg tablet, film coated, extended release | Generic | $0.8901 per tablet |
| tramadol hydrochloride 200 mg capsule | Generic | $9.85 per capsule |
| tramadol hydrochloride 200 mg tablet, extended release | Generic | $1.39 per tablet |
| tramadol hydrochloride 200 mg tablet, film coated, extended release | Generic | $1.39 per tablet |
| tramadol hydrochloride 25 mg tablet, coated | Generic | $3.38 per tablet |
| tramadol hydrochloride 300 mg tablet, extended release | Generic | $2.07 per tablet |
| tramadol hydrochloride 300 mg tablet, film coated, extended release | Generic | $2.07 per tablet |
| tramadol hydrochloride 50 mg tablet | Generic | $0.0260 per tablet |
| tramadol hydrochloride 50 mg tablet, coated | Generic | $0.0260 per tablet |
| tramadol hydrochloride 50 mg tablet, film coated | Generic | $0.0260 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- Proficient Rx LP11 products
- Bryant Ranch Prepack11 products
- Asclemed USA, Inc.10 products
- Advanced Rx Pharmacy of Tennessee, LLC7 products
- Lupin Pharmaceuticals, Inc.6 products
- Preferred Pharmaceuticals Inc.6 products
- Sun Pharmaceutical Industries, Inc.6 products
- NuCare Pharmaceuticals, Inc.5 products
- Remedyrepack Inc.5 products
- Direct_Rx4 products
- Rising Pharma Holdings, Inc.4 products
- Advanced Rx of Tennessee, LLC4 products
- Advagen Pharma Limited4 products
- Macleods Pharmaceuticals Limited3 products
- Vertical Pharmaceuticals, LLC3 products
- TruPharma, LLC3 products
- Trigen Laboratories, LLC3 products
- Coupler LLC3 products
- Quality Care Products, LLC3 products
- A-S Medication Solutions3 products
- Strides Pharma Science Limited2 products
- St. Mary's Medical Park Pharmacy2 products
- Northwind Health Company, LLC2 products
- Amneal Pharmaceuticals NY LLC2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Medsource Pharmaceuticals1 product
- Golden State Medical Supply, Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- RedPharm Drug, Inc.1 product
- Clinical Solutions Wholesale, LLC1 product
- Major Pharmaceuticals1 product
- Unit Dose Solutions, Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
- American Health Packaging1 product
- Cranbury Pharmaceuticals, LLC1 product
- Unichem Pharmaceuticals (USA), Inc.1 product
- Aurobindo Pharma Limited1 product
- DirectRx1 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 |
|---|---|---|---|
| NDA022370 CONZIP | Cipher Pharms Inc | May 7, 2010 | 17, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
| NDA214044 QDOLO | Rosemont | September 1, 2020 | 5, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
Generic approvals (12)
- ANDA075977Teva · June 19, 2002
- ANDA076003Amneal Pharms · June 20, 2002
- ANDA075968Graviti Pharms · June 25, 2002
- ANDA200503Lupin Ltd · August 29, 2011
- ANDA202075Strides Pharma · November 28, 2011
- ANDA201384Sun Pharm · December 7, 2011
- ANDA091607Sun Pharm · December 30, 2011
- ANDA091498Cspc Ouyi Pharm Co · March 29, 2013
- ANDA203494Aurobindo Pharma Ltd · March 31, 2014
- ANDA208708Rubicon Research · June 28, 2019
- ANDA211825Unichem · August 9, 2019
- ANDA209404Macleods Pharms · January 31, 2025
Shortage status
The FDA drug shortage list does not show these products.
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.
-
March 19, 2026 · Class II · Ongoing · D-0408-2026
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219 — Amneal Pharmaceuticals, LLC
-
April 26, 2024 · Class II · Ongoing · D-0487-2024
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited — Rubicon Research Private Limited
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — ConZip, Vertical Pharmaceuticals, LLC, effective December 29, 2025; 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 →