Drug
Who makes codeine sulfate?
2 companies list codeine sulfate as a human prescription drug. Forms: tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing codeine sulfate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | tablet | NDANDA022402 | 3 | 4 |
| Lannett Company, LLCUnited States | tablet | ANDAANDA203046 | 3 | 1 |
Bulk ingredient listings
- SpecGx LLCUnited States · 1 NDC
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Common questions
- Who makes codeine sulfate?
- 2 companies list codeine sulfate as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., Lannett Company, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic codeine sulfate?
- 1 company lists codeine sulfate under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies codeine sulfate active ingredient?
- 1 company lists codeine sulfate as a bulk ingredient, including SpecGx LLC.