Progesterone
- Product NDC
- 0054-0830
- 11-digit product format
- 000540830
- Labeler code
- 0054
- Product ID
- 0054-0830_f38dd5d9-88b1-4792-bbb9-5f589d9539b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Progesterone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc
- Application
- ANDA200456
- Marketing category
- ANDA
- Marketing start
- 2025-05-15
- Substance
- PROGESTERONE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Progesterone [CS], Progesterone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Progesterone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROGESTERONE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4G7DS2Q64Y |
| Rxcui | 260243, 312641 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0830-25 | Progesterone | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0830 | PROGESTERONE CAPSULE [HIKMA PHARMACEUTICALS USA INC] | 1 | Current NDC, 1 package rows | 20250515_d8bcc439-c21d-4eeb-9159-f51e0c60bd70.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0830-25 | 00054083025 | 100 CAPSULE in 1 BOTTLE (0054-0830-25) | 100 capsule | 2025-05-15 | No | No | Current |