Metoprolol Tartrate and Hydrochlorothiazide
- Product NDC
- 62756-369
- 11-digit product format
- 627560369
- Labeler code
- 62756
- Product ID
- 62756-369_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; 50 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
- 2026-12-31
- 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 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… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090654-002 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;100MG | TABLET / ORAL | 2012-01-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090654-003 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 50MG;100MG | TABLET / ORAL | 2012-01-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090654-001 | METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE | 25MG;50MG | TABLET / ORAL | 2012-01-19 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A090654-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090654-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090654-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090654-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090654-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090654-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090654-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090654-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090654-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090654-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090654-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090654-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090654-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090654-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090654-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090654-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090654-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A090654-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090654-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090654-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A090654-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090654-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090654-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090654-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090654-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090654-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A090654-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090654-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090654-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A090654-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090654-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090654-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A090654-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090654-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090654-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A090654-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090654-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090654-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A090654-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090654-001 | AB | 1 | ea99ee380514… |
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
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METOPROLOL TARTRATE | 100 mg/1 |
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W5S57Y3A5L | Internal UNII lookup |
| 0J48LPH2TH | 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 |
|---|---|---|---|---|---|---|
| 62756-369-08 | Metoprolol Tartrate and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | 10 | |
| 62756-369-18 | Metoprolol Tartrate and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | 10 | |
| 62756-369-83 | Metoprolol Tartrate and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | 10 | |
| 62756-369-88 | 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 |
|---|---|---|---|---|---|
| 62756-369-88 | EA - Each | 62756-369 | d8f3f9aa-2ac3-4191-a0bd-2f14622eeeaf | 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 62756-369 |
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 |
|---|---|---|---|---|---|---|---|---|
| 62756-369-08 | 62756036908 | 100 TABLET in 1 BOTTLE (62756-369-08) | 100 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-369-18 | 62756036918 | 1000 TABLET in 1 BOTTLE (62756-369-18) | 1000 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-369-83 | 62756036983 | 30 TABLET in 1 BOTTLE (62756-369-83) | 30 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |
| 62756-369-88 | 62756036988 | 100 TABLET in 1 BOTTLE (62756-369-88) | 100 tablet | 2022-04-01 | 0000-00-00 | No | No | Current |