Misoprostol
- Product NDC
- 55154-2145
- 11-digit product format
- 551542145
- Labeler code
- 55154
- Product ID
- 55154-2145_d2ee7acd-0b65-4391-b2d1-397afc4da168
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Misoprostol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA076095
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- 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#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-2145-0 | Misoprostol | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
| 55154-2145-0 | Misoprostol | 10 in 1 BAG | TABLET | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-2145 | MISOPROSTOL TABLET [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20241215_52a82e45-afc5-47d0-a77f-a225609e2f6b.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 |
|---|
| 55154-2145-0 | 55154214500 | 10 BLISTER PACK in 1 BAG (55154-2145-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-12-10 | No | No | Current |