Metoprolol Tartrate and Hydrochlorothiazide
- Product NDC
- 62756-368
- 11-digit product format
- 627560368
- Labeler code
- 62756
- Product ID
- 62756-368_99595af6-8c5d-4dc7-8396-e7bce050bb3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metoprolol Tartrate and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090654
- Marketing category
- ANDA
- Marketing start
- 2022-04-01
- Substance
- METOPROLOL TARTRATE; HYDROCHLOROTHIAZIDE
- Active strength
- 100; 25 mg/1; mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], 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 |
|---|---|---|---|---|---|---|---|
| A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | ||
| A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | ||
| A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE | 50MG;100MG | TABLET / ORAL | 2012-01-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A090654-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A090654-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090654-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090654-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090654-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090654-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090654-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A090654-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090654-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090654-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A090654-003 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090654-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090654-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090654-003 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090654-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090654-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090654-003 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090654-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090654-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090654-003 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090654-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090654-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090654-003 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090654-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A090654-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A090654-003 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090654-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A090654-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A090654-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090654-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090654-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090654-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090654-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A090654-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A090654-003 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090654-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A090654-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A090654-003 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090654-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090654-002 | AB | 1 | cb3db0bc1861… |
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
- Metoprolol Tartrate and Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METOPROLOL TARTRATE | 100 mg/1 |
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| W5S57Y3A5L | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-368-08 | Metoprolol Tartrate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 62756-368-18 | Metoprolol Tartrate and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | 10 | |
| 62756-368-83 | Metoprolol Tartrate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 62756-368-88 | Metoprolol Tartrate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62756-368-88 | EA - Each | 62756-368 | 39ee5a92-d38a-4dd6-8f39-daecfc95dd91 | 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 |
|---|---|---|---|---|---|---|
| Metoprolol Tartrate and Hydrochlorothiazide | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | Sun Pharmaceutical Industries, Inc. | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 2024-01-02 | Warnings, Adverse reactions | 090654 ANDA090654 62756-368 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866479 | metoprolol tartrate 100 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866491 | metoprolol tartrate 100 MG / hydroCHLOROthiazide 50 MG Oral Tablet | PSN | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866482 | metoprolol tartrate 50 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866479 | hydrochlorothiazide 25 MG / metoprolol tartrate 100 MG Oral Tablet | SCD | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866482 | hydrochlorothiazide 25 MG / metoprolol tartrate 50 MG Oral Tablet | SCD | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866491 | hydrochlorothiazide 50 MG / metoprolol tartrate 100 MG Oral Tablet | SCD | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866479 | HCTZ 25 MG / metoprolol tartrate 100 MG Oral Tablet | SY | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866482 | HCTZ 25 MG / metoprolol tartrate 50 MG Oral Tablet | SY | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
| 866491 | HCTZ 50 MG / metoprolol tartrate 100 MG Oral Tablet | SY | faaf13ce-5d8d-4c57-a49f-a7a73daa41a5 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-368-08 | 62756036808 | 100 TABLET in 1 BOTTLE (62756-368-08) | 100 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-368-18 | 62756036818 | 1000 TABLET in 1 BOTTLE (62756-368-18) | 1000 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-368-83 | 62756036883 | 30 TABLET in 1 BOTTLE (62756-368-83) | 30 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-368-88 | 62756036888 | 100 TABLET in 1 BOTTLE (62756-368-88) | 100 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |