Prometrium
- Product NDC
- 72989-373
- 11-digit product format
- 729890373
- Labeler code
- 72989
- Product ID
- 72989-373_3d2fed08-88a5-4645-b158-33527a2556eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Progesterone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Acertis Pharmaceuticals, LLC
- Application
- NDA019781
- Marketing category
- NDA
- Marketing start
- 2022-11-01
- 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
- Prometrium
- 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, 261319, 262080, 312641 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72989-373-30 | Prometrium | 30 in 1 BOTTLE | CAPSULE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72989-373 | PROMETRIUM (PROGESTERONE) CAPSULE [ACERTIS PHARMACEUTICALS, LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240312_1cf237ff-c4f8-4faa-a7aa-77599c856889.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 |
|---|
| 72989-373-30 | 72989037330 | 30 CAPSULE in 1 BOTTLE (72989-373-30) | 30 capsule | 2022-11-01 | 0000-00-00 | No | No | Current |