Misoprostol
- Product NDC
- 54348-148
- 11-digit product format
- 543480148
- Labeler code
- 54348
- Product ID
- 54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MISOPROSTOL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA091667
- Marketing category
- ANDA
- Marketing start
- 2019-07-10
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-148 | MISOPROSTOL TABLET [PHARMPAK, INC.] | 3 | Current NDC, Legacy NDC, 16 package rows | 20221011_b07b3dfc-1cb5-484c-be11-8d14c89c794f.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 |
|---|
| 54348-148-00 | 54348014800 | 1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-01 | 54348014801 | 1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-02 | 54348014802 | 1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-03 | 54348014803 | 1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-04 | 54348014804 | 1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-06 | 54348014806 | 1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-08 | 54348014808 | 1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |
| 54348-148-09 | 54348014809 | 1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE | 1 bottle | 2019-07-10 | 0000-00-00 | No | No | Current |