Mifepristone
- Product NDC
- 43393-001
- 11-digit product format
- 433930001
- Labeler code
- 43393
- Product ID
- 43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIFEPRISTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GenBioPro, Inc.
- Application
- ANDA091178
- Marketing category
- ANDA
- Marketing start
- 2019-05-01
- Substance
- MIFEPRISTONE
- Active strength
- 200 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 | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 320T6RNW1F |
| Rxcui | 311704 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43393-001-01 | Mifepristone | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
| 43393-001-06 | Mifepristone | 6 in 1 PACKAGE | TABLET | 6 | | 9 |
| 43393-001-06 | Mifepristone | 1 in 1 CARTON | TABLET | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43393-001 | MIFEPRISTONE TABLET [GENBIOPRO, INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20230404_b63fad9b-7f12-4400-9019-b0586054e534.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 |
|---|
| 43393-001-01 | 43393000101 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 43393-001-06 | 43393000106 | 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01) | 6 carton | 2019-05-01 | 0000-00-00 | No | No | Current |