Atenolol
- Product NDC
- 0615-8027
- Requested package NDC
- 0615-8027-05
- 11-digit product format
- 006158027
- Labeler code
- 0615
- Product ID
- 0615-8027_e3f0cfd2-cf6f-4676-9730-d5c23d49e853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, Inc dba Vangard Labs
- Application
- ANDA074056
- Marketing category
- ANDA
- Marketing start
- 1995-02-22
- Marketing end
- 2022-09-30
- Substance
- ATENOLOL
- Active strength
- 50 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0615-8027 | 0615-8027-05 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074056-001 | ATENOLOL | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | |
| A074056-002 | ATENOLOL | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | |
| A074056-003 | ATENOLOL | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074056-001 | AB |
| A074056-002 | AB |
| A074056-003 | 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 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | 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 | A074056-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074056-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074056-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074056-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074056-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074056-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074056-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074056-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074056-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074056-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074056-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A074056-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074056-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074056-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074056-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A074056-001 | AB | 1 | 8072bd15b7f6… |
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 | QPharma, Inc. | 70d7a585-7a46-4eac-b2b5-2ac5b98d9882 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | PD-Rx Pharmaceuticals, Inc. | 95761173-1c95-46b2-a08f-fbc3e70daba8 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | PD-Rx Pharmaceuticals, Inc. | c69b8e5e-c7c3-4883-9cea-f7f435a8ede8 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Aphena Pharma Solutions - Tennessee, LLC | 23e96396-85d3-0d8e-e063-6394a90a614d | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Aphena Pharma Solutions - Tennessee, LLC | 247569d6-9a73-f1d0-e063-6394a90a667a | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | NuCare Pharmaceuticals,Inc. | 7366c6f8-4cb3-520e-e053-2991aa0a2cc8 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Teva Pharmaceuticals USA, Inc. | 25a72ec9-de0f-44e5-90b8-da1aab0d3588 | 2024-05-31 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | A-S Medication Solutions | d73a475a-c8c9-44a0-89ac-6a2d665c0d24 | 2023-12-26 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Proficient Rx LP | 24f1f3f4-bbda-458b-b15f-d942c90534e2 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Bryant Ranch Prepack | ba0b0221-d4b3-4cb1-9435-53a75fcc4b40 | 2020-07-07 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
| Atenolol | ATENOLOL | Proficient Rx LP | b198b34c-861a-4b52-b4df-8c48b807520a | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 074056 ANDA074056 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0615-8027-05 | 00615802705 | 15 TABLET in 1 BLISTER PACK (0615-8027-05) | 15 tablet | 2016-05-05 | 2022-09-30 | No | No | Current |