Carvedilol
- Product NDC
- 51655-034
- 11-digit product format
- 516550034
- Labeler code
- 51655
- Product ID
- 51655-034_46ddb2f3-3674-237a-e063-6294a90aa52c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2022-08-09
- Substance
- CARVEDILOL
- Active strength
- 3.125 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 | 3.125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-034-25 | Carvedilol | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 4 |
| 51655-034-52 | Carvedilol | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
| 51655-034-83 | Carvedilol | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-034 | CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 3 | Current NDC, 3 package rows | 20240704_f2a0407c-2e05-60eb-e053-2a95a90abc99.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-034-25 | 51655003425 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-034-25) | 2022-10-18 | No | No | Current |
| 51655-034-52 | 51655003452 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-034-52) | 2022-08-09 | No | No | Current |
| 51655-034-83 | 51655003483 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-034-83) | 2023-01-11 | No | No | Current |