Atenolol
- Product NDC
- 67544-161
- 11-digit product format
- 675440161
- Labeler code
- 67544
- Product ID
- 67544-161_d38bdacd-b80a-4e86-b588-5a6eede1d075
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA074052
- Marketing category
- ANDA
- Marketing start
- 1992-05-01
- 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
- 2020-12-31
- 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 product | product | 67544-161 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 67544-161 | 67544-161-30 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 67544-161 | 67544-161-45 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 67544-161 | 67544-161-60 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 67544-161 | 67544-161-80 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 67544-161 | 67544-161-92 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67544-161-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67544-161-80 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67544-161-92 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67544-161-45 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 67544-161-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67544-161-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67544-161-80 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67544-161-92 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67544-161-45 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 67544-161-30 | f5e01cc5f278… | a2eaf40c39c3… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A074052-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 1992-05-01 | 74a2ff9319b5… | |
| 2019-12-14 00:12 UTC | 2019-12 | A074052-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 1992-05-01 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074052-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 1992-05-01 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074052-001 | ATENOLOL | 25MG | TABLET / ORAL | AB | 1992-05-01 | ea99ee380514… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A074052-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A074052-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074052-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074052-001 | AB | 1 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67544-161-30 | EA - Each | 67544-161 | 201663d2-3295-40cd-962f-4724e0153bb4 | 1 | 2013-02-13 |
| 67544-161-45 | EA - Each | 67544-161 | 2106cfc1-5677-4cbe-9477-0fb5c56d5139 | 1 | 2013-02-13 |
| 67544-161-60 | EA - Each | 67544-161 | bb25113d-afea-41d1-9ad4-15c8a42bf751 | 1 | 2013-02-13 |
| 67544-161-80 | EA - Each | 67544-161 | 840038dd-45b2-484c-8c74-787d8290995f | 1 | 2013-02-13 |
| 67544-161-92 | EA - Each | 67544-161 | 4e575fa6-3dc2-4d27-b380-0917bbaad2bb | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ATENOLOL | ACTIVE INGREDIENT | 50VV3VW0TI | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| ATENOLOL | ACTIVE MOIETY | 50VV3VW0TI | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 2 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67544-161-30 | 67544016130 | 30 TABLET in 1 BOTTLE, PLASTIC (67544-161-30) | 30 tablet | 2009-06-30 | 0000-00-00 | No | No | Current |
| 67544-161-45 | 67544016145 | 45 TABLET in 1 BOTTLE, PLASTIC (67544-161-45) | 45 tablet | 2009-06-30 | 0000-00-00 | No | No | Current |
| 67544-161-60 | 67544016160 | 90 TABLET in 1 BOTTLE, PLASTIC (67544-161-60) | 90 tablet | 2004-06-30 | 0000-00-00 | No | No | Current |
| 67544-161-80 | 67544016180 | 180 TABLET in 1 BOTTLE, PLASTIC (67544-161-80) | 180 tablet | 2008-02-26 | 0000-00-00 | No | No | Current |
| 67544-161-92 | 67544016192 | 270 TABLET in 1 BOTTLE, PLASTIC (67544-161-92) | 270 tablet | 2011-10-24 | 0000-00-00 | No | No | Current |