Carvedilol
- Product NDC
- 82009-125
- 11-digit product format
- 820090125
- Labeler code
- 82009
- Product ID
- 82009-125_4645b74b-2d36-4e20-9a06-e300949eb89e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Quallent Pharmaceuticals Health LLC
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2023-08-03
- 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 | 200031, 200032, 200033, 686924 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-125-05 | Carvedilol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-125 | CARVEDILOL TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 2 | Current NDC, 1 package rows | 20231221_eb892787-edd0-4ab6-aef2-2d0216384395.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82009-125-05 | 82009012505 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-125-05) | 2023-08-03 | No | No | Historical |