Ambrisentan
- Product NDC
- 0378-4271
- 11-digit product format
- 003784271
- Labeler code
- 0378
- Product ID
- 0378-4271_e6cdba8a-c9be-460b-918a-f72bd6310bce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA208441
- Marketing category
- ANDA
- Marketing start
- 2019-04-29
- Substance
- AMBRISENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ambrisentan
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMBRISENTAN | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HW6NV07QEC |
| Rxcui | 722116, 722122 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-4271-93 | Ambrisentan | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-4271 | AMBRISENTAN TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250427_8080b009-361b-4505-b09a-0d91a0e4a2c0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-4271-93 | 00378427193 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4271-93) | 2019-04-29 | 0000-00-00 | No | No | Current |