Carvedilol
- Product NDC
- 68071-3138
- 11-digit product format
- 680713138
- Labeler code
- 68071
- Product ID
- 68071-3138_0ec45c14-def9-b2b9-e063-6294a90a3a3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA077614
- Marketing category
- ANDA
- Marketing start
- 2007-09-05
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARVEDILOL | 3.125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K47UL67F2 |
| Rxcui | 686924 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3138-3 | 2020-05-07 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-6 | 2020-05-07 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-8 | 2020-05-07 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-9 | 2020-05-07 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
| 68071-3138-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8194-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use. Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3138-3 | Carvedilol | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68071-3138-6 | Carvedilol | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68071-3138-8 | Carvedilol | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 4 |
| 68071-3138-9 | Carvedilol | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3138 | CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 4 package rows | 20240113_49afdf89-0bed-71da-e054-00144ff88e88.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 |
|---|
| 68071-3138-3 | 68071313803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3138-3) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68071-3138-6 | 68071313806 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3138-6) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68071-3138-8 | 68071313808 | 180 TABLET, FILM COATED in 1 BOTTLE (68071-3138-8) | 2017-03-01 | 0000-00-00 | No | No | Current |
| 68071-3138-9 | 68071313809 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3138-9) | 2017-03-01 | 0000-00-00 | No | No | Current |