PROGESTERONE
- Product NDC
- 0591-3128
- 11-digit product format
- 005913128
- Labeler code
- 0591
- Product ID
- 0591-3128_aacccc63-aa7d-435e-bec5-0aab0e04153f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PROGESTERONE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA017362
- Marketing category
- NDA
- Marketing start
- 1978-05-11
- 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 |
|---|
| 0591-3128-79 | PROGESTERONE | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROGESTERONE | ACTIVE INGREDIENT | 4G7DS2Q64Y | PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 17 | |
| PROGESTERONE | ACTIVE MOIETY | 4G7DS2Q64Y | PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 17 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 17 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 17 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3128 | PROGESTERONE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 23 | Current NDC, Legacy NDC, 1 package rows | 20221006_a09a3b76-36f1-4d20-930e-7e3da97e7ebd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-3128-79 | 00591312879 | 10 mL in 1 VIAL, MULTI-DOSE (0591-3128-79) | 10 ml | 1978-05-11 | 0000-00-00 | No | No | Current |