METOPROLOL TARTRATE
- Product NDC
- 53401-015
- 11-digit product format
- 534010015
- Labeler code
- 53401
- Product ID
- 53401-015_547539d4-e52d-8bd9-e063-6394a90af5a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METOPROLOL TARTRATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA200981
- Marketing category
- ANDA
- Marketing start
- 2026-02-09
- Substance
- METOPROLOL TARTRATE
- Active strength
- 25 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 |
|---|---|---|---|---|---|---|---|
| A200981-001 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | |
| A200981-002 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | |
| A200981-003 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | |
| A200981-004 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | |
| A200981-005 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A200981-001 | AB |
| A200981-002 | AB |
| A200981-003 | AB |
| A200981-004 | AB |
| A200981-005 | 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 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2014-10-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2014-10-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2014-10-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-004 | METOPROLOL TARTRATE | 37.5MG | TABLET / ORAL | AB | 2019-08-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-005 | METOPROLOL TARTRATE | 75MG | TABLET / ORAL | AB | 2019-08-21 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A200981-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200981-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200981-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200981-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A200981-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A200981-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200981-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200981-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200981-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A200981-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A200981-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200981-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A200981-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200981-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200981-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200981-005 | AB | 1 | 03ed91905a0d… |
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
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METOPROLOL TARTRATE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W5S57Y3A5L | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 866924 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54754388-39c9-9a02-e063-6394a90a90b3 | Available on FDA.report |
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 | METOPROLOL TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 522c3807-855e-20a3-e063-6394a90abeb7 | 2026-05-19 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 522cc739-1252-4689-e063-6294a90ad1b0 | 2026-05-19 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | ef6a817b-58c5-45bc-b5a2-22c31b05c0ab | 2026-05-19 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | A-S Medication Solutions | 2bcfb9d9-e092-4a0a-ac55-bad532de360c | 2026-05-19 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | ASCLEMED USA INC. | df3492c3-b71a-40d8-838b-031ebca969d8 | 2026-05-18 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | NuCare Pharmaceuticals, Inc. | 4f9ba91b-ecfc-10cc-e063-6294a90ae236 | 2026-04-16 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | ST. MARY'S MEDICAL PARK PHARMACY | 4f845cbb-81a2-72c4-e063-6394a90a96d6 | 2026-04-15 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | QPharma, Inc. | 4dcb79e6-19de-67fb-e063-6294a90afde0 | 2026-04-10 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Bryant Ranch Prepack | 840ac287-cae5-4c07-82d5-546fb04414ef | 2026-04-09 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Bryant Ranch Prepack | 22f1b399-83ad-4c2e-bb17-c11967a7471e | 2026-04-09 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Redpharm Drug | 4ce1c1ef-bc9a-1397-e063-6294a90a3bda | 2026-03-13 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | PD-Rx Pharmaceuticals, Inc. | 4cdbfc5d-2572-39b0-e063-6394a90af5f2 | 2026-03-12 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Bryant Ranch Prepack | 77fb1898-871f-489f-bc0b-933dd08a9bc4 | 2026-03-11 | Warnings, Adverse reactions | 200981 ANDA200981 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Direct_Rx | 13b7404f-e16b-5d43-e063-6394a90a3fca | 2026-03-05 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Exelan Pharmaceuticals, Inc. | f54b250d-bd15-483b-b191-a664291382c1 | 2026-02-27 | Warnings, Adverse reactions | 200981 ANDA200981 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Direct_Rx | 499ce022-12a7-e4e5-e063-6394a90a435a | 2026-01-30 | Warnings, Adverse reactions | 200981 ANDA200981 |
| METOPROLOL TARTRATE | METOPROLOL TARTRATE | Advagen Pharma Limited | a401fe31-d51a-49d9-a062-c9d22088db56 | 2026-01-13 | Warnings, Adverse reactions | 200981 ANDA200981 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Direct_Rx | 3bb62867-cf85-ce6d-e063-6294a90ad17f | 2026-01-08 | Warnings, Adverse reactions | 200981 ANDA200981 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Northwind Health Company, LLC | e07d2929-7f78-cf63-e053-2995a90af82b | 2026-01-01 | Warnings, Adverse reactions | 200981 ANDA200981 |
| Metoprolol Tartrate | METOPROLOL TARTRATE | Northwind Health Company, LLC | d9df7d01-339c-8985-e053-2a95a90a0d2c | 2026-01-01 | Warnings, Adverse reactions | 200981 ANDA200981 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 53401-015-53 | 53401001553 | 60 TABLET in 1 BOTTLE (53401-015-53) | 60 tablet | 2026-06-16 | No | No | Current |
| 53401-015-60 | 53401001560 | 90 TABLET in 1 BOTTLE (53401-015-60) | 90 tablet | 2026-06-16 | No | No | Current |
| 53401-015-80 | 53401001580 | 180 TABLET in 1 BOTTLE (53401-015-80) | 180 tablet | 2026-06-16 | No | No | Current |
| 53401-015-92 | 53401001592 | 270 TABLET in 1 BOTTLE (53401-015-92) | 270 tablet | 2026-06-16 | No | No | Current |
| 53401-015-98 | 53401001598 | 540 TABLET in 1 BOTTLE (53401-015-98) | 540 tablet | 2026-06-16 | No | No | Current |