Data / Drug companies / Hikma Pharmaceuticals USA Inc.
Hikma Pharmaceuticals USA Inc.: 215 products in the FDA NDC directory, labeler code 0054
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Hikma Pharmaceuticals USA Inc. (labeler code 0054) lists 215 products in the FDA National Drug Code Directory, covering 82 finished drugs by generic name. By type: 215 prescription drugs. Its main marketing category is generic drugs (ANDA). The newest product started marketing on October 8, 2026.
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- Labeler code
- 0054
- Products in commercial distribution
- 215
- Packages
- 282
- Finished drugs by generic name
- 82
- Prescription products
- 215
- Over the counter products
- 0
- Controlled substance products
- Schedule II 39, Schedule III 7, Schedule IV 8, Schedule V 1
- Flagged as original packager
- 200 of 200 products that carry the flag
- Started marketing in the last 12 months
- 26
- Products with a marketing end date set
- 2
- Earliest marketing start
- April 21, 1972
- openFDA record search
- api.fda.gov
Products by marketing category
Share of the company's products in commercial distribution.
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 177 | 82.3% |
| New drug applications (NDA) | 27 | 12.6% |
| Authorized generics (NDA) | 11 | 5.1% |
Products by type
| Type | Products | Share |
|---|---|---|
| Prescription drugs | 215 | 100% |
Drugs it lists
Finished drugs by generic name, with how many companies list each.
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 99 | 46% |
| Capsule | 33 | 15.3% |
| Solution | 27 | 12.6% |
| Tablet, film coated, extended release | 8 | 3.7% |
| Capsule, gelatin coated | 8 | 3.7% |
| Tablet, film coated | 7 | 3.3% |
| Suspension | 5 | 2.3% |
| Solution, concentrate | 5 | 2.3% |
| Powder | 3 | 1.4% |
| Tablet, coated | 3 | 1.4% |
| Concentrate | 3 | 1.4% |
| Spray, metered | 2 | 0.9% |
Pharmacologic classes
FDA established pharmacologic classes of its products.
Newest products
By marketing start date.
| Product | Product NDC | Dosage form | Marketing category | Marketing start |
|---|---|---|---|---|
| Neomycin and Polymyxin B sulfates and Hydrocortisone OTIC | 0054-0975 | Solution/ drops | Generic drugs (ANDA) | October 8, 2026 |
| Deflazacort | 0054-0827 | Tablet | Generic drugs (ANDA) | October 7, 2026 |
| Deflazacort | 0054-0826 | Tablet | Generic drugs (ANDA) | October 7, 2026 |
| Deflazacort | 0054-0825 | Tablet | Generic drugs (ANDA) | October 7, 2026 |
| Deflazacort | 0054-0824 | Tablet | Generic drugs (ANDA) | October 7, 2026 |
| Fidaxomicin | 0054-0795 | Tablet, coated | Generic drugs (ANDA) | October 7, 2026 |
| Cevimeline hydrochloride | 0054-0893 | Capsule | Generic drugs (ANDA) | October 5, 2026 |
| Dicyclomine hydrochloride | 0054-0883 | Capsule | Generic drugs (ANDA) | September 15, 2026 |
| Dicyclomine hydrochloride | 0054-0885 | Tablet | Generic drugs (ANDA) | September 10, 2026 |
| Lithium Carbonate | 0054-0891 | Capsule, gelatin coated | New drug applications (NDA) | August 16, 2026 |
| Lithium Carbonate | 0054-0890 | Capsule, gelatin coated | New drug applications (NDA) | August 16, 2026 |
| Lithium Carbonate | 0054-0887 | Capsule, gelatin coated | New drug applications (NDA) | August 16, 2026 |
| Lithium Carbonate | 0054-0886 | Tablet | New drug applications (NDA) | August 16, 2026 |
| Tofacitinib solution | 0054-0821 | Solution | Generic drugs (ANDA) | June 3, 2026 |
| Eltrombopag | 0054-0965 | Tablet | Generic drugs (ANDA) | April 24, 2026 |
| Eltrombopag | 0054-0964 | Tablet | Generic drugs (ANDA) | April 24, 2026 |
| Eltrombopag | 0054-0963 | Tablet | Generic drugs (ANDA) | April 24, 2026 |
| Eltrombopag | 0054-0962 | Tablet | Generic drugs (ANDA) | April 24, 2026 |
| Tapentadol | 0054-0945 | Tablet, film coated | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0943 | Tablet, film coated | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0942 | Tablet, film coated | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0940 | Tablet, film coated, extended release | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0939 | Tablet, film coated, extended release | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0938 | Tablet, film coated, extended release | Authorized generics (NDA) | December 15, 2025 |
| Tapentadol | 0054-0937 | Tablet, film coated, extended release | Authorized generics (NDA) | December 15, 2025 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.