Carvedilol
- Product NDC
- 0781-5223
- 11-digit product format
- 007815223
- Labeler code
- 0781
- Product ID
- 0781-5223_56b48372-0a73-4242-a65c-2b65abdb70c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- ANDA078227
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Marketing end
- 2026-08-31
- Substance
- CARVEDILOL
- Active strength
- 12.5 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 12.5 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 |
|---|
| 0781-5223-01 | Carvedilol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 11 |
| 0781-5223-29 | Carvedilol | 60 in 1 BLISTER PACK | TABLET, FILM COATED | 60 | | 11 |
| 0781-5223-60 | Carvedilol | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POVIDONE K12 | INACTIVE INGREDIENT | 333AG72FWJ | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [MAJOR PHARMACEUTICALS] | 6 | |
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-5223 | CARVEDILOL TABLET, FILM COATED [SANDOZ INC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250425_da8b8c20-0130-4aa9-924d-4a4f28c3f767.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 |
|---|
| 0781-5223-01 | 00781522301 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5223-01) | 2007-09-05 | 2026-08-31 | No | No | Current |
| 0781-5223-29 | 00781522329 | 60 in 1 BLISTER PACK | | | | | Historical |
| 0781-5223-60 | 00781522360 | 60 in 1 BOTTLE | | | | | Historical |