Quick answers
- What is Orphenadrine citrate used for?
- The FDA-approved label (Orphenadrine Citrate, Remedyrepack Inc., August 10, 2026) says: “Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Orphenadrine citrate have a boxed warning?
- No. None of the 20 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Orphenadrine citrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Orphenadrine citrate been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started March 21, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Orphenadrine citrate?
- 17 companies list prescription products of Orphenadrine citrate in the FDA NDC Directory, including Advanced Rx Pharmacy of Tennessee, LLC, Proficient Rx LP and Bryant Ranch Prepack.
What Orphenadrine citrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
— FDA label: Orphenadrine Citrate, Remedyrepack Inc., effective August 10, 2026. Read the full label on DailyMed →
The FDA has 20 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.
The label quoted above has no boxed warning.
0 of 20 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, extended release · Injection · Injection, solution |
|---|---|
| Route | Oral · Intramuscular · Intravenous |
| Prescription products | 20 in the FDA NDC Directory |
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 |
|---|---|---|
| orphenadrine citrate 100 mg tablet, extended release | Generic | $0.4799 per tablet |
| orphenadrine citrate 30 mg/mL injection, solution | Generic | $5.73 per mL |
| orphenadrine citrate 60 mg/2 mL injection | Generic | $7.07 per mL |
NADAC list of November 4, 2026; these prices took effect between July 22, 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.
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Proficient Rx LP2 products
- Bryant Ranch Prepack2 products
- A-S Medication Solutions1 product
- Redpharm Drug1 product
- Actavis Pharma, Inc.1 product
- Northwind Health Company, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
- Remedyrepack Inc.1 product
- Lake Erie Medical DBA Quality Care Products LLC1 product
- Lupin Pharmaceuticals, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Preferred Pharmaceuticals Inc.1 product
- Sagent Pharmaceuticals1 product
- St. Mary's Medical Park Pharmacy1 product
- Sandoz Inc1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA084779Watson Labs · March 15, 1982
- ANDA040284Lupin · June 19, 1998
- ANDA040327Sandoz · February 15, 2000
- ANDA040463Hikma · March 4, 2003
- ANDA090585Sagent Pharms · August 30, 2011
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 21, 2022 · Class II · Terminated · D-0753-2022
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01. — Sandoz, Inc
-
July 11, 2014 · Class III · Terminated · D-1445-2014
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. — Sandoz Inc
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) | 994521, 994541 |
|---|---|
| SPL set ID of the quoted label | 7905e80f-b60b-48e8-8e63-a3e50211bfe4 |
| FDA labels (SPL) | 20 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | ORPHENADRINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Orphenadrine Citrate, Remedyrepack Inc., effective August 10, 2026; 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 →