Misoprostol
- Product NDC
- 40032-160
- 11-digit product format
- 400320160
- Labeler code
- 40032
- Product ID
- 40032-160_b702ac6b-e9de-04a9-e053-2995a90a908d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA091667
- Marketing category
- ANDA
- Marketing start
- 2012-07-25
- Substance
- MISOPROSTOL
- Active strength
- 100 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 | 100 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0E43V0BB57 |
| Rxcui | 311727, 317128 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 40032-160-06 | Misoprostol | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 40032-160-12 | Misoprostol | 120 in 1 BOTTLE | TABLET | 120 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40032-160 | MISOPROSTOL TABLET [NOVEL LABORATORIES, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20201222_a46d05a2-5014-40ff-8f1b-9eca1b0aff3a.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 |
|---|
| 40032-160-06 | 40032016006 | 60 TABLET in 1 BOTTLE (40032-160-06) | 60 tablet | 2012-07-25 | 0000-00-00 | No | No | Current |
| 40032-160-12 | 40032016012 | 120 TABLET in 1 BOTTLE (40032-160-12) | 120 tablet | 2012-07-25 | 0000-00-00 | No | No | Current |