Prescription drug · ANDA
Progesterone NDC 0054-0829
Progesterone 100 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0829-25 | 00054082925 | 100 CAPSULE in 1 BOTTLE (0054-0829-25)Marketed from May 15, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Progesterone
- Generic name (nonproprietary)
- progesterone
- Active ingredients
- Progesterone — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200456
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone (Chemical structure)
- Identifiers
- Product ID 0054-0829_f38dd5d9-88b1-4792-bbb9-5f589d9539b0SPL ID f38dd5d9-88b1-4792-bbb9-5f589d9539b0SPL set ID d8bcc439-c21d-4eeb-9159-f51e0c60bd70RxCUI 260243, 312641UNII 4G7DS2Q64Y
- Pharmacologic class
- Progesterone
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054082925followed by a unit qualifier and the quantityPackage 00054-0829-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Progesterone Capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200456
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Progesterone | Progesterone 200 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0830 |