Misoprostol
- Product NDC
- 43393-024
- 11-digit product format
- 433930024
- Labeler code
- 43393
- Product ID
- 43393-024_28a4139f-35d2-8ea3-e063-6394a90a0812
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- GenBioPro, Inc.
- Application
- ANDA210201
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Misoprostol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MISOPROSTOL | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57 |
| Rxcui | 317128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43393-024-04 | Misoprostol | 4 in 1 BOTTLE | TABLET | 4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43393-024 | MISOPROSTOL TABLET [GENBIOPRO, INC.] | 1 | Current NDC, 1 package rows | 20241211_28a4138c-f302-5109-e063-6394a90a94fa.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 |
|---|
| 43393-024-04 | 43393002404 | 4 TABLET in 1 BOTTLE (43393-024-04) | 4 tablet | 2024-12-16 | No | No | Historical |