Atenolol and Chlorthalidone
- Product NDC
- 0591-5782
- Requested package NDC
- 0591-5782-01
- 11-digit product format
- 005915782
- Labeler code
- 0591
- Product ID
- 0591-5782_ea2e1205-e570-4d89-bd7a-b5ec4022abab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Atenolol and Chlorthalidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA073665
- Marketing category
- ANDA
- Marketing start
- 1992-08-01
- 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 |
|---|---|---|---|---|---|---|---|
| A073665-001 | ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | |
| A073665-002 | ATENOLOL AND CHLORTHALIDONE | ATENOLOL; CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073665-001 | AB |
| A073665-002 | 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 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073665-001 | ATENOLOL AND CHLORTHALIDONE | 50MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073665-002 | ATENOLOL AND CHLORTHALIDONE | 100MG;25MG | TABLET / ORAL | AB | 1992-07-02 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A073665-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A073665-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A073665-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A073665-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A073665-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A073665-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073665-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073665-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A073665-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A073665-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073665-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073665-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073665-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073665-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073665-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073665-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073665-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073665-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073665-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073665-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073665-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073665-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A073665-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A073665-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073665-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073665-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073665-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073665-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073665-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073665-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A073665-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A073665-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073665-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073665-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A073665-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A073665-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A073665-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A073665-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A073665-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A073665-002 | AB | 1 | 74a2ff9319b5… |
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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 50VV3VW0TI | Internal UNII lookup |
| Q0MQD1073Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a6794dfa-adbb-491b-9d48-f89a44e866c5 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 0591-5782-01 | Atenolol and Chlorthalidone | 100 in 1 BOTTLE | TABLET | 100 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-5782-01 | EA - Each | 0591-5782 | f136f95e-0bdf-46b5-ad57-611bd753b3f3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | PD-Rx Pharmaceuticals, Inc. | 78b374f8-0e16-4c15-85c1-16609ac3aca2 | 2025-10-20 | Warnings, Adverse reactions | 073665 ANDA073665 |
| Atenolol and Chlorthalidone | ATENOLOL AND CHLORTHALIDONE | Actavis Pharma, Inc. | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 2024-03-01 | Warnings, Adverse reactions | 073665 ANDA073665 0591-5782-01 0591-5782 00591578201 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | 78b374f8-0e16-4c15-85c1-16609ac3aca2 | 20 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | 78b374f8-0e16-4c15-85c1-16609ac3aca2 | 20 |
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | PSN | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 17 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 17 |
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | SCD | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 17 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | a6794dfa-adbb-491b-9d48-f89a44e866c5 | 17 |
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | PSN | cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | 18a6026b-a790-44b6-bf03-a17a1a7dac7a | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | 73705d59-49fa-4e5d-8e3b-13bc2ac8796b | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | PSN | cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 | 1 |
| 197382 | atenolol 100 MG / chlorthalidone 25 MG Oral Tablet | SCD | cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | 18a6026b-a790-44b6-bf03-a17a1a7dac7a | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | 73705d59-49fa-4e5d-8e3b-13bc2ac8796b | 1 |
| 197383 | atenolol 50 MG / chlorthalidone 25 MG Oral Tablet | SCD | cd4f6a14-a2eb-4157-83a7-91ab4e9926e5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-5782-01 | 00591578201 | 100 TABLET in 1 BOTTLE (0591-5782-01) | 100 tablet | 1992-08-01 | 0000-00-00 | No | No | Current |