Atenolol
- Product NDC
- 64980-438
- 11-digit product format
- 649800438
- Labeler code
- 64980
- Product ID
- 64980-438_7bf7d854-7736-4159-81e0-2f9f0c12d73c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA077443
- Marketing category
- ANDA
- Marketing start
- 2010-06-10
- Substance
- ATENOLOL
- Active strength
- 50 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], 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 |
|---|---|---|---|---|---|---|---|
| A077443-001 | ATENOLOL | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | |
| A077443-002 | ATENOLOL | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | |
| A077443-003 | ATENOLOL | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077443-001 | AB |
| A077443-002 | AB |
| A077443-003 | 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 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-002 | ATENOLOL | 50MG | TABLET / ORAL | AB | 2006-09-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-003 | ATENOLOL | 100MG | TABLET / ORAL | AB | 2006-09-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077443-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2006-09-13 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077443-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077443-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077443-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077443-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077443-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077443-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077443-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077443-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077443-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077443-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077443-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077443-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077443-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077443-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077443-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077443-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atenolol
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATENOLOL | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50VV3VW0TI | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96dd038f-b363-4e24-9c67-82b7c85c3bc4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| faf41ef3-b4b3-a29e-3b26-07c3009003bf | Product name | 5 | 20220517 |
| 5eb1a708-d713-e905-0a08-b103c64796f4 | Product name | 3 | 20201019 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64980-438-01 | Atenolol | 100 in 1 BOTTLE | TABLET | 100 | 5 | |
| 64980-438-10 | Atenolol | 1000 in 1 BOTTLE | TABLET | 1000 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-438-01 | EA - Each | 64980-438 | 0c8ed00d-39f6-4540-a859-c70b7a60cef6 | 1 | 2018-02-20 |
| 64980-438-10 | EA - Each | 64980-438 | e836bc5a-292c-4557-88f3-28a8bb8446cb | 1 | 2018-02-20 |
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 |
|---|---|---|---|---|---|---|
| Atenolol | ATENOLOL | St. Mary's Medical Park Pharmacy | 7f8304a4-93de-774f-e053-2a91aa0aa5b5 | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | St Mary's Medical Park Pharmacy | 78d394b8-8ffb-a846-e053-2991aa0aa58c | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | St. Mary's Medical Park Pharmacy | 8501f6c1-8157-4189-e053-2a91aa0ac4ef | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals, Inc. | 26d3df38-20c6-40e0-a456-da4f10fff632 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals, Inc. | a8d48a47-ccab-4a35-a092-6e562683ade3 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals Inc. | 82100fc8-5a5a-4d80-8101-72024ee0abef | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| atenolol | ATENOLOL | direct rx | b3c757de-1cbf-61f5-e053-2995a90accfc | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | A-S Medication Solutions | 43acd912-f0f4-47eb-b81f-cbbfed77c557 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | A-S Medication Solutions | e4ece8f4-3714-42ba-b36d-d00586dfd33a | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Northwind Health Company, LLC | db5bd8e2-1314-0f7f-e053-2995a90ae86e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | QPharma, Inc. | bd43e0b1-c05e-01ae-e053-2a95a90af1cd | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Rising Pharma Holdings, Inc. | 96dd038f-b363-4e24-9c67-82b7c85c3bc4 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 64980-438 |
| Atenolol | ATENOLOL | NuCare Pharmaceuticals,Inc. | 8115a2bc-69aa-60b4-e053-2a91aa0aeae7 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Direct_Rx | ee143f2f-be60-bc67-e053-2a95a90ae6e6 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| ATENOLOL | ATENOLOL | direct rx | b3d9f826-7ed7-1e3b-e053-2995a90ae731 | 2025-01-17 | Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | NuCare Pharmaceuticals,Inc. | 9db36b04-f353-55d6-e053-2a95a90ae08f | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Bryant Ranch Prepack | 722d6532-20d0-4936-ae9c-b7bb593b960a | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Bryant Ranch Prepack | c7a8830a-5eda-4f0e-bf03-61ee8ed6558d | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | Bryant Ranch Prepack | 1d6ea66b-30ef-4829-b757-5ea9d412a666 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
| Atenolol | ATENOLOL | NuCare Pharmaceuticals,Inc. | 73671d55-3e10-cb1d-e053-2991aa0ac038 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 077443 ANDA077443 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64980-438-01 | 64980043801 | 100 TABLET in 1 BOTTLE (64980-438-01) | 100 tablet | 2010-06-10 | 0000-00-00 | No | No | Current |
| 64980-438-10 | 64980043810 | 1000 TABLET in 1 BOTTLE (64980-438-10) | 1000 tablet | 2010-06-10 | 0000-00-00 | No | No | Current |