Quick answers
- What is Codeine sulfate used for?
- The FDA-approved label (Codeine sulfate, Hikma Pharmaceuticals USA Inc., December 22, 2025) says: “Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Codeine sulfate have a boxed warning?
- Yes. The FDA label for Codeine sulfate has a boxed warning (“WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF CODEINE SULFATE TABLETS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Codeine sulfate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Codeine sulfate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Codeine sulfate?
- 2 companies list prescription products of Codeine sulfate in the FDA NDC Directory, including Lannett Company, Inc. and Hikma Pharmaceuticals USA Inc..
What Codeine sulfate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Codeine Sulfate Tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Limitations of Use …
— FDA label: Codeine sulfate, Hikma Pharmaceuticals USA Inc., effective December 22, 2025. Read the full label on DailyMed →
The FDA has 2 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 CODEINE SULFATE TABLETS
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 6 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 |
|---|---|---|
| codeine sulfate 15 mg tablet | Generic | $0.6770 per tablet |
| codeine sulfate 30 mg tablet | Generic | $0.7458 per tablet |
| codeine sulfate 60 mg tablet | Generic | $1.25 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.
- Lannett Company, Inc.3 products
- Hikma Pharmaceuticals USA Inc.3 products
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 |
|---|---|---|---|
| NDA022402 CODEINE SULFATE | Hikma | July 16, 2009 | 13, latest June 18, 2026 2026: REMS · 2025: Labeling · 2024: REMS |
Generic approvals (1)
- ANDA203046Lannett Co Inc · June 13, 2014
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 997170, 997287, 997296 |
|---|---|
| SPL set ID of the quoted label | 010905f9-3bcb-4b50-9fe8-a3ad0010f14c |
| FDA labels (SPL) | 2 |
| FDA applications | NDA022402, 1 ANDA |
| Active ingredients (FDA) | CODEINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Codeine sulfate, Hikma Pharmaceuticals USA Inc., effective December 22, 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 →