Mifepristone
- Product NDC
- 76346-654
- 11-digit product format
- 763460654
- Labeler code
- 76346
- Product ID
- 76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mifepristone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Corcept Therapeutics Incorporated
- Application
- NDA202107
- Marketing category
- NDA
- Marketing start
- 2024-05-28
- 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 |
|---|
| 76346-654-03 | Mifepristone | 280 in 1 BOTTLE | TABLET | 280 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76346-654 | MIFEPRISTONE TABLET [CORCEPT THERAPEUTICS INCORPORATED] | 2 | Current NDC, 1 package rows | 20250130_63c068cd-9370-460f-829b-70e8c7ebe91e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76346-654-03 | 76346065403 | 280 TABLET in 1 BOTTLE (76346-654-03) | 280 tablet | 2024-05-28 | No | No | Current |