Mifepristone
- Product NDC
- 0591-4390
- 11-digit product format
- 005914390
- Labeler code
- 0591
- Product ID
- 0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mifepristone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA211436
- Marketing category
- ANDA
- Marketing start
- 2024-01-19
- Substance
- MIFEPRISTONE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mifepristone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIFEPRISTONE | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 320T6RNW1F |
| Rxcui | 1245262 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-4390-96 | Mifepristone | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-4390 | MIFEPRISTONE TABLET, FILM COATED [ACTAVIS PHARMA, INC.] | 1 | Current NDC, 1 package rows | 20240120_5e09acc0-fd26-4722-b8b3-46e560390d47.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0591-4390-96 | 00591439096 | 28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96) | 2024-01-19 | No | No | Current |