Carvedilol
- Product NDC
- 0093-0135
- 11-digit product format
- 000930135
- Labeler code
- 0093
- Product ID
- 0093-0135_3d07d8c6-ffea-41c3-a50c-4e3d723de14f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA076373
- Marketing category
- ANDA
- Marketing start
- 2007-09-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076373-001 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | |
| A076373-002 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A076373-003 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | |
| A076373-004 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076373-001 | AB |
| A076373-002 | AB |
| A076373-003 | AB |
| A076373-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-001 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-002 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-003 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-004 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076373-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076373-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076373-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076373-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076373-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076373-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076373-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076373-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076373-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076373-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076373-004 | AB | 1 | d06236e962d9… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Carvedilol | CARVEDILOL | A-S Medication Solutions | fe2d5c95-c101-4b01-89fd-0fd6d25ad80b | 2026-04-26 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a | 2026-03-01 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | QPharma, Inc. | ffbedcce-0d64-4aed-9e65-09448d71ca91 | 2025-12-05 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | 52785a22-ddca-4f5b-8579-5974df2a9a4e | 2025-12-01 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | NCS HealthCare of KY, LLC dba Vangard Labs | 2fb46fe1-9b7b-4718-9327-2471af22f0b7 | 2025-06-11 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | da2696ba-f4be-4626-9abe-fe33f36361b1 | 2025-05-01 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | Proficient Rx LP | c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85 | 2025-02-01 | Warnings, Adverse reactions | 076373 ANDA076373 |
| Carvedilol | CARVEDILOL | Teva Pharmaceuticals USA, Inc. | 68c275e8-992a-4520-8065-ab6d615d89cc | 2024-03-25 | Warnings, Adverse reactions | 076373 ANDA076373 0093-0135 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Carvedilol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CARVEDILOL | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K47UL67F2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 68c275e8-992a-4520-8065-ab6d615d89cc | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-0135-01 | Carvedilol | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 16 | |
| 0093-0135-05 | Carvedilol | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-0135-01 | EA - Each | 0093-0135 | 4ef2379f-a6b5-49fc-b27e-45c97c732405 | 1 | 2012-07-24 |
| 0093-0135-05 | EA - Each | 0093-0135 | e84c5b0d-972c-4d97-8d6a-832d9347631d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0093-0135-01 | 00093013501 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0135-01) | 2007-09-06 | 0000-00-00 | No | No | Current |
| 0093-0135-05 | 00093013505 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0135-05) | 2008-12-02 | 0000-00-00 | No | No | Current |