Metoprolol Tartrate
- Product NDC
- 0904-6341
- Requested package NDC
- 0904-6341-80
- 11-digit product format
- 009046341
- Labeler code
- 0904
- Product ID
- 0904-6341_1d470f32-a887-4db7-9c82-a71be8ad6263
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metoprolol Tartrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA202871
- Marketing category
- ANDA
- Marketing start
- 2014-03-14
- Marketing end
- 0000-00-00
- Substance
- METOPROLOL TARTRATE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0904-6341 | 0904-6341-80 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202871-001 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | |
| A202871-002 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | |
| A202871-003 | METOPROLOL TARTRATE | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202871-001 | AB |
| A202871-002 | AB |
| A202871-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-002 | METOPROLOL TARTRATE | 50MG | TABLET / ORAL | AB | 2013-05-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-003 | METOPROLOL TARTRATE | 100MG | TABLET / ORAL | AB | 2013-05-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202871-001 | METOPROLOL TARTRATE | 25MG | TABLET / ORAL | AB | 2013-05-28 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A202871-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202871-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202871-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202871-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202871-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202871-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202871-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202871-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202871-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202871-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202871-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202871-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202871-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202871-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202871-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202871-001 | AB | 1 | 1e350fbaab3a… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6341-60 | EA - Each | 0904-6341 | 9498e27f-9406-42db-9ac9-d59fd21fae8a | 1 | 2014-02-04 |
| 0904-6341-80 | EA - Each | 0904-6341 | b6f4b6eb-16d0-4a92-aa41-5f4f1e1926d4 | 1 | 2014-02-04 |
DailyMed Socrata Ingredients#
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 | REMEDYREPACK INC. | 58d493d3-b69c-422a-b6a8-0f8fa1e55545 | 2026-08-04 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Bryant Ranch Prepack | 00940cc5-d2eb-4841-9138-de97d7b1c674 | 2026-07-27 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Northwind Health Company, LLC | 471ccbfe-96dd-7ab9-e063-6394a90a5bd6 | 2026-07-21 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | REMEDYREPACK INC. | e1c99d45-8f42-46b1-b770-14d0eb2b300a | 2026-06-24 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Coupler LLC | 512711ea-a3be-6de6-e063-6394a90a9109 | 2026-05-06 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Proficient Rx LP | 95b95aab-0733-4189-b4c0-429a1046c534 | 2026-04-01 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | NuCare Pharmaceuticals, Inc. | 47d11c0c-82dd-33b1-e063-6394a90a6a97 | 2026-01-07 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Northwind Health Company, LLC | 106b7a0c-af7f-2565-e063-6294a90a34e0 | 2026-01-01 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | NCS HealthCare of KY, LLC dba Vangard Labs | c97e7527-b44e-48ca-b6be-53999bf5554b | 2025-08-21 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Inc. | 24837d82-0f3f-4482-9af0-31e5f675c30f | 2024-08-22 | Warnings, Adverse reactions | 202871 ANDA202871 |
| METOPROLOL TARTRATE | METOPROLOL | Alembic Pharmaceuticals Limited | cb76a73f-549a-4170-b96a-f93ed7e09464 | 2023-05-10 | Warnings, Adverse reactions | 202871 ANDA202871 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6341-80 | 00904634180 | 1000 TABLET in 1 BOTTLE (0904-6341-80) | 1000 tablet | 2014-03-14 | 0000-00-00 | No | No | Current |