Carvedilol
- Product NDC
- 65841-617
- 11-digit product format
- 658410617
- Labeler code
- 65841
- Product ID
- 65841-617_98f78a02-849a-4540-85f8-f0ea1eb1f8f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- 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 |
|---|
| 65841-617-01 | Carvedilol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 10 |
| 65841-617-05 | Carvedilol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 10 |
| 65841-617-17 | Carvedilol | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65841-617 | CARVEDILOL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] | 9 | Current NDC, Legacy NDC, 3 package rows | 20241128_29082d8c-bbde-4620-924f-02dcf1764919.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 |
|---|
| 65841-617-01 | 65841061701 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-617-01) | 2007-09-05 | 0000-00-00 | No | No | Current |
| 65841-617-05 | 65841061705 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-617-05) | 2007-09-05 | 0000-00-00 | No | No | Current |
| 65841-617-17 | 65841061717 | 28 TABLET, FILM COATED in 1 BOTTLE (65841-617-17) | 2007-09-05 | 0000-00-00 | No | No | Current |