Carvedilol
- Product NDC
- 67296-0681
- 11-digit product format
- 672960681
- Labeler code
- 67296
- Product ID
- 67296-0681_1ba40f55-ff0f-4b7d-b104-ce85f04cf9c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RedPharm Drug Inc.
- Application
- ANDA078251
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- Marketing end
- 0000-00-00
- Substance
- CARVEDILOL
- Active strength
- 13 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e148a93c-bfff-2735-e6c0-0739297b4596 | Product name | 3 | 20180705 |
| 32d6365f-9f0e-0782-b719-48e651893fb7 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67296-0681-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c44f-8e05-e053-dbdaa90a074a | These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets, USP. Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67296-0681-1 | Carvedilol | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CARVEDILOL | ACTIVE INGREDIENT | 0K47UL67F2 | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| CARVEDILOL | ACTIVE MOIETY | 0K47UL67F2 | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67296-0681 | CARVEDILOL TABLET [REDPHARM DRUG INC.] | 1 | Legacy NDC, 1 package rows | 20110824_da8a670b-a9ce-445f-af31-7588c6c67e29.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200032 | carvedilol 12.5 MG Oral Tablet | PSN | da8a670b-a9ce-445f-af31-7588c6c67e29 | 1 |
| 200032 | carvedilol 12.5 MG Oral Tablet | SCD | da8a670b-a9ce-445f-af31-7588c6c67e29 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 67296-0681-1 | 67296068101 | 60 in 1 BOTTLE | Historical |