Atenolol
- Product NDC
- 53002-1108
- Requested package NDC
- 53002-1108-1
- 11-digit product format
- 530021108
- Labeler code
- 53002
- Product ID
- 53002-1108_2507724a-897f-4cab-bd08-0576e8743e46
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA074056
- Marketing category
- ANDA
- Marketing start
- 2004-11-16
- Marketing end
- 0000-00-00
- Substance
- ATENOLOL
- Active strength
- 25 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 53002-1108 | 53002-1108-1 | I | Inactivated by FDA | 2026-07-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A074056-001 | ATENOLOL | 50MG | TABLET / ORAL | AB | 1995-01-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A074056-002 | ATENOLOL | 100MG | TABLET / ORAL | AB | 1995-01-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A074056-003 | ATENOLOL | 25MG | TABLET / ORAL | AB | 2004-07-19 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A074056-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A074056-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A074056-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| 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 |
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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1108-0 | Atenolol | 100 in 1 BOTTLE | TABLET | 100 | 11 | |
| 53002-1108-1 | Atenolol | 10 in 1 BOTTLE | TABLET | 10 | 11 | |
| 53002-1108-3 | Atenolol | 30 in 1 BOTTLE | TABLET | 30 | 11 | |
| 53002-1108-6 | Atenolol | 60 in 1 BOTTLE | TABLET | 60 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1108 | ATENOLOL TABLET [RPK PHARMACEUTICALS, INC.] | 11 | Legacy NDC, 4 package rows | 20230609_616bf08d-5adf-4d10-9a2e-bcb536b7c2e0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197379 | atenolol 100 MG Oral Tablet | PSN | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
| 197380 | atenolol 25 MG Oral Tablet | PSN | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
| 197381 | atenolol 50 MG Oral Tablet | PSN | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
| 197379 | atenolol 100 MG Oral Tablet | SCD | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
| 197380 | atenolol 25 MG Oral Tablet | SCD | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
| 197381 | atenolol 50 MG Oral Tablet | SCD | 616bf08d-5adf-4d10-9a2e-bcb536b7c2e0 | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1108-1 | 53002110801 | 10 TABLET in 1 BOTTLE (53002-1108-1) | 10 tablet | 2018-10-01 | 0000-00-00 | No | No | Current |