Progesterone
- Product NDC
- 63323-261
- 11-digit product format
- 633230261
- Labeler code
- 63323
- Product ID
- 63323-261_e03e68a3-f9df-4c3f-bd1f-30fae68433f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROGESTERONE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA075906
- Marketing category
- ANDA
- Marketing start
- 2001-07-19
- Substance
- PROGESTERONE
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Progesterone [CS], Progesterone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Progesterone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROGESTERONE | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4G7DS2Q64Y |
| Rxcui | 312644 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-261-10 | Progesterone | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63323-261-10 | Progesterone | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-261 | PROGESTERONE (PROGESTERONE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241019_a479b395-1e1a-4d2a-8feb-68a15c47225f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63323-261-10 | 63323026110 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2001-07-19 | 0000-00-00 | No | No | Current |