Carvedilol
- Product NDC
- 71335-1623
- 11-digit product format
- 713351623
- Labeler code
- 71335
- Product ID
- 71335-1623_b6e60516-209f-4738-ade3-6a8c1baf8205
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Substance
- CARVEDILOL
- Active strength
- 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
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 71335-1623_b6e60516-209f-4738-ade3-6a8c1baf8205
- SPL ID
- b6e60516-209f-4738-ade3-6a8c1baf8205
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Carvedilol
- Generic name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing start
- 2007-09-05
- Marketing category
- ANDA
- Application number
- ANDA077614
- Pharmacologic classes
- Adrenergic alpha-Antagonists [MoA]; Adrenergic beta1-Antagonists [MoA]; Adrenergic beta2-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]; beta-Adrenergic Blocker [EPC]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| CARVEDILOL | 25 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 200032, 200033 |
| Spl Set Id | 196536eb-8b94-45da-a2f3-f554d6bf88e9 |
| Manufacturer Name | Bryant Ranch Prepack |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71335-1623-1 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1623-1) | 2007-09-05 | No |
| 71335-1623-2 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1623-2) | 2007-09-05 | No |
| 71335-1623-3 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1623-3) | 2007-09-05 | No |
| 71335-1623-4 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1623-4) | 2007-09-05 | No |
| 71335-1623-5 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1623-5) | 2007-09-05 | No |
| 71335-1623-6 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1623-6) | 2007-09-05 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 0K47UL67F2 | CARVEDILOL | 72956-09-3 | CARVEDILOL |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-1623-1 | 71335162301 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1623-1) | 2007-09-05 | No | No | Historical |
| 71335-1623-2 | 71335162302 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1623-2) | 2007-09-05 | No | No | Historical |
| 71335-1623-3 | 71335162303 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1623-3) | 2007-09-05 | No | No | Historical |
| 71335-1623-4 | 71335162304 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1623-4) | 2007-09-05 | No | No | Historical |
| 71335-1623-5 | 71335162305 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1623-5) | 2007-09-05 | No | No | Historical |
| 71335-1623-6 | 71335162306 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1623-6) | 2007-09-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Carvedilol | Bryant Ranch Prepack | 2024-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 4 |