Atenolol and Chlorthalidone
- Product NDC
- 70710-1167
- 11-digit product format
- 707101167
- Labeler code
- 70710
- Product ID
- 70710-1167_49c5d516-1ea5-4232-98c6-03be7e814768
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol and Chlorthalidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA210028
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- Substance
- ATENOLOL; CHLORTHALIDONE
- Active strength
- 50; 25 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], 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 |
|---|---|---|---|---|---|---|---|
| A210028-001 | ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | |
| A210028-002 | ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210028-001 | AB |
| A210028-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210028-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210028-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 2019-03-08 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A210028-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A210028-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A210028-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A210028-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210028-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210028-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A210028-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A210028-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A210028-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A210028-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A210028-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A210028-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A210028-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A210028-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A210028-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A210028-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A210028-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A210028-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210028-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210028-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A210028-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A210028-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A210028-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A210028-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210028-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210028-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210028-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210028-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210028-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210028-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210028-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210028-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A210028-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A210028-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A210028-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A210028-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210028-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210028-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A210028-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A210028-002 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Atenolol and Chlorthalidone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ATENOLOL | 50 mg/1 |
| CHLORTHALIDONE | 25 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 83fe98fe-2a14-448c-9029-41f7600d1b0a | Product name | 1 | 20260105 |
| 0450926f-f624-49c2-83be-42807e8fbcd5 | Product name | 1 | 20251113 |
| 8525e779-537f-e5cc-2515-089ecce5f50f | Product name | 9 | 20221128 |
| faf41ef3-b4b3-a29e-3b26-07c3009003bf | Product name | 5 | 20220517 |
| 5eb1a708-d713-e905-0a08-b103c64796f4 | Product name | 3 | 20201019 |
| 3f5e2da3-8b99-f714-3261-2c998ee07b05 | Product name | 1 | 20140508 |
| 7667d8e2-e5be-36e1-4de7-231aa7fdaf5c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70710-1167-1 | Atenolol and Chlorthalidone | 100 in 1 BOTTLE | TABLET | 100 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70710-1167-1 | EA - Each | 70710-1167 | 0c3c6f7a-1a79-448a-9cca-104b6fcfbf1d | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70710-1167 | ATENOLOL AND CHLORTHALIDONE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240110_69131547-f554-4980-b54e-007afc2c696e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | PSN | 69131547-f554-4980-b54e-007afc2c696e | 4 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | 69131547-f554-4980-b54e-007afc2c696e | 4 |
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | SCD | 69131547-f554-4980-b54e-007afc2c696e | 4 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | 69131547-f554-4980-b54e-007afc2c696e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70710-1167-1 | 70710116701 | 100 TABLET in 1 BOTTLE (70710-1167-1) | 100 tablet | 2019-03-12 | 0000-00-00 | No | No | Current |