Carvedilol
- Product NDC
- 76385-111
- 11-digit product format
- 763850111
- Labeler code
- 76385
- Product ID
- 76385-111_4aa597d4-9141-4bef-a4d5-03b111958338
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- UNICHEM PHARMACEUTICALS (USA), INC.
- Application
- ANDA078384
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- Substance
- CARVEDILOL
- Active strength
- 6.25 mg/1
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 6.25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 200031, 200032, 200033, 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76385-111-01 | Carvedilol | 100 in 1 BOTTLE, PLASTIC | Tablet, FILM COATED | 100 | | 8 |
| 76385-111-50 | Carvedilol | 500 in 1 BOTTLE, PLASTIC | Tablet, FILM COATED | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76385-111 | CARVEDILOL TABLET, FILM COATED [BAYSHORE PHARMACEUTICALS LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240614_33dfcf29-19d6-46ba-b8ed-d59d2226ad07.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 |
|---|
| 76385-111-01 | 76385011101 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-01) | 2016-10-01 | 0000-00-00 | No | No | Current |
| 76385-111-50 | 76385011150 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-50) | 2016-10-01 | 0000-00-00 | No | No | Current |