Misoprostol
- Product NDC
- 10135-746
- 11-digit product format
- 101350746
- Labeler code
- 10135
- Product ID
- 10135-746_e0fafb4b-404d-5fd6-e053-2995a90a5d60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA076095
- Marketing category
- ANDA
- Marketing start
- 2022-06-01
- Marketing end
- 0000-00-00
- Substance
- MISOPROSTOL
- Active strength
- 200 ug/1
- Pharmacologic classes
- Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-746-60 | Misoprostol | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-746 | MISOPROSTOL TABLET [MARLEX PHARMACEUTICALS, INC.] | 2 | Legacy NDC, 1 package rows | 20230306_e0fafb40-74fb-a9df-e053-2995a90a3caa.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 |
|---|
| 10135-746-60 | 10135074660 | 60 TABLET in 1 BOTTLE (10135-746-60) | 60 tablet | 2022-06-01 | 0000-00-00 | No | No | Current |