Ambrisentan
- Product NDC
- 69097-387
- 11-digit product format
- 690970387
- Labeler code
- 69097
- Product ID
- 69097-387_7921a3aa-6e99-4f28-a5d3-a3047b1ec3cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ambrisentan
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA210715
- Marketing category
- ANDA
- Marketing start
- 2019-04-26
- Substance
- AMBRISENTAN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ambrisentan
- Listing expiration
- 2026-12-31
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 |
|---|
| 69097-387-02 | Ambrisentan | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 8 |
| 69097-387-19 | Ambrisentan | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 8 |
| 69097-387-19 | Ambrisentan | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-387 | AMBRISENTAN TABLET, FILM COATED [CIPLA USA INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20221229_0e418384-cae1-47ae-ac5e-afc845d694f6.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 |
|---|
| 69097-387-02 | 69097038702 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69097-387-02) | | 2019-04-26 | 0000-00-00 | No | No | Current |
| 69097-387-19 | 69097038719 | 1 BLISTER PACK in 1 CARTON (69097-387-19) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2019-04-26 | 0000-00-00 | No | No | Current |