TENORMIN
- Product NDC
- 24979-246
- 11-digit product format
- 249790246
- Labeler code
- 24979
- Product ID
- 24979-246_c804fa73-5b5a-4e20-a1f5-6a13155df21f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- NDA018240
- Marketing category
- NDA
- Marketing start
- 2024-08-01
- Substance
- ATENOLOL
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018240-001 | TENORMIN | ATENOLOL | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N018240-002 | TENORMIN | ATENOLOL | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| N018240-004 | TENORMIN | ATENOLOL | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018240-001 | AB |
| N018240-002 | AB |
| N018240-004 | 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 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-002 | TENORMIN | 100MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-004 | TENORMIN | 25MG | TABLET / ORAL | AB | RLD | 1990-04-09 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018240-001 | TENORMIN | 50MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 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 | N018240-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018240-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018240-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018240-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018240-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018240-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018240-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018240-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018240-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018240-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018240-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018240-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018240-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018240-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018240-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018240-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TENORMIN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATENOLOL | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50VV3VW0TI | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a | 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 |
|---|---|---|---|---|---|---|
| 24979-246-07 | TENORMIN | 90 in 1 BOTTLE | TABLET | 90 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24979-246-07 | EA - Each | 24979-246 | ab5db31e-5e18-4cca-9e07-dfec9c75c559 | 1 | 2025-05-14 |
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 |
|---|---|---|---|---|---|---|
| TENORMIN | ATENOLOL | Upsher-Smith Laboratories, LLC | 6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a | 2025-09-18 | Warnings, Adverse reactions | 018240 NDA018240 24979-246 |
| TENORMIN | ATENOLOL | Almatica Pharma LLC | 746db603-a6e1-4dc3-c2d8-92314419098c | 2023-11-15 | Warnings, Adverse reactions | 018240 NDA018240 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 24979-246-07 | 24979024607 | 90 TABLET in 1 BOTTLE (24979-246-07) | 90 tablet | 2024-08-01 | No | No | Current |