Carvedilol
- Product NDC
- 63187-424
- Requested package NDC
- 63187-424-60
- 11-digit product format
- 631870424
- Labeler code
- 63187
- Product ID
- 63187-424_bb200a44-7b5a-475f-aebb-e9e132f00a21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Carvedilol
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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
- 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 |
|---|---|---|---|---|---|---|---|
| A077614-001 | CARVEDILOL | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-002 | CARVEDILOL | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-003 | CARVEDILOL | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | |
| A077614-004 | CARVEDILOL | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077614-001 | AB |
| A077614-002 | AB |
| A077614-003 | AB |
| A077614-004 | 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 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-004 | CARVEDILOL | 3.125MG | TABLET / ORAL | AB | 2007-09-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-001 | CARVEDILOL | 6.25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-002 | CARVEDILOL | 12.5MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-003 | CARVEDILOL | 25MG | TABLET / ORAL | AB | 2007-09-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-004 | CARVEDILOL | 3.125MG | 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 | A077614-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077614-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077614-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077614-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077614-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077614-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077614-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077614-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077614-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077614-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077614-004 | AB | 1 | d06236e962d9… |
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#
| Identifier | FDA.report destination |
|---|---|
| 200031 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d5822e3c-413c-4c7e-bbec-d0d42d2028ba | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c09e7fc3-90f5-4f9d-96f4-e1a857de4102 | Product name | 1 | 20230718 |
| 36aa7500-f1f6-4316-9cf2-688d1cdea23a | Product name | 1 | 20190402 |
| e148a93c-bfff-2735-e6c0-0739297b4596 | Product name | 3 | 20180705 |
| 15592b85-0e03-4d08-b78d-bef98f30a3f5 | Product name | 1 | 20180529 |
| 32d6365f-9f0e-0782-b719-48e651893fb7 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-424-30 | Carvedilol | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 63187-424-60 | Carvedilol | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-424-30 | EA - Each | 63187-424 | 03e109b1-ae4b-4175-93c8-95e5f5622fbf | 1 | 2026-02-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | ab8aa773-0ed1-4d59-a1bb-f46cf882644f | 2026-07-30 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 0e98593a-8424-48c8-acc0-671f4b566aee | 2026-07-14 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 32098c09-7580-4975-a3e1-31b619c04c69 | 2026-07-06 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | 196536eb-8b94-45da-a2f3-f554d6bf88e9 | 2026-06-29 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb | 2026-06-26 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 39cf31cc-8f3d-4919-a93a-f997ad6850dc | 2026-06-25 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | REMEDYREPACK INC. | 6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f | 2026-06-01 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | St. Mary's Medical Park Pharmacy | ed11cd4e-d7c9-8446-e053-2995a90afd6e | 2026-06-01 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Coupler LLC | 52bd1d20-08ba-1e5e-e063-6294a90ae8a9 | 2026-05-26 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Coupler LLC | 51b403dc-fc9f-0cad-e063-6394a90af081 | 2026-05-13 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | QPharma Inc | 010290af-81f4-0037-e063-6394a90a4638 | 2026-05-11 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | St. Mary's Medical Park Pharmacy | 8a82149f-aade-2a9b-e053-2995a90a9daf | 2026-05-05 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Bryant Ranch Prepack | b23021d4-c00a-e0ef-eb93-1dc824ae56ca | 2026-04-02 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals, Inc. | 5c34847d-68f9-4967-81c8-a2297a6acb7f | 2026-03-23 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Preferred Pharmaceuticals Inc. | 3b56e0d0-82d7-4512-849f-2b72d7bae36e | 2026-03-20 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | BluePoint Laboratories | e68c9b18-e7fd-45f7-a8f5-1d815e32680b | 2026-03-09 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c48ba6b-4e1e-5116-e063-6394a90aa793 | 2026-03-05 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | Direct_Rx | 4c0e089b-0199-43e2-e063-6394a90a7883 | 2026-03-02 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | 3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231 | 2026-02-13 | Warnings, Adverse reactions | 077614 ANDA077614 |
| Carvedilol | CARVEDILOL | A-S Medication Solutions | add1ee3d-fca4-4301-b871-7dda6eda7bb7 | 2026-02-13 | Warnings, Adverse reactions | 077614 ANDA077614 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 200031 | carvedilol 6.25 MG Oral Tablet | PSN | d5822e3c-413c-4c7e-bbec-d0d42d2028ba | 4 |
| 200031 | carvedilol 6.25 MG Oral Tablet | SCD | d5822e3c-413c-4c7e-bbec-d0d42d2028ba | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-424-60 | 63187042460 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-424-60) | 2018-12-01 | 0000-00-00 | No | No | Current |