Metoprolol Succinate
- Product NDC
- 0378-4597
- 11-digit product format
- 003784597
- Labeler code
- 0378
- Product ID
- 0378-4597_786400ee-3153-460a-8eb5-cbe59164dbf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metoprolol succinate
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202033
- Marketing category
- ANDA
- Marketing start
- 2019-01-02
- Marketing end
- 0000-00-00
- Substance
- METOPROLOL SUCCINATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 product | product | 0378-4597 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 0378-4597 | 0378-4597-10 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 0378-4597 | 0378-4597-77 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202033-001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | ||
| A202033-002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | ||
| A202033-003 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | ||
| A202033-004 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 |
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 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2011-12-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202033-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202033-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202033-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202033-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-12-15 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202033-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202033-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202033-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202033-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202033-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202033-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202033-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202033-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202033-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202033-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202033-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202033-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202033-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202033-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202033-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202033-004 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202033-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202033-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202033-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202033-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202033-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202033-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202033-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202033-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202033-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202033-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202033-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202033-004 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202033-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202033-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202033-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202033-004 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202033-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202033-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202033-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202033-004 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202033-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202033-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202033-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202033-004 | AB | 1 | 782e0a99824c… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fac0d979-ed64-4395-be9a-fc0b6f8c0a4f | Product name | 1 | 20260122 |
| e1a63b6e-1877-c2c1-01a3-03ea2817aa6f | Product name | 3 | 20251027 |
| 07ea0487-5434-6896-2497-013a7ee4afbd | Product name | 9 | 20250311 |
| 95ced987-af5e-4bea-8119-4e7d4558d21b | Product name | 2 | 20200617 |
| 47fc2fe9-7afb-4be9-989d-787aaa6ad0ea | Product name | 1 | 20200505 |
| 9ab5a42a-e77d-486b-bb1f-b343fe664ada | Product name | 1 | 20180430 |
| 310125de-e7c0-730d-d178-98b990a0334a | Product name | 2 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0378-4597-10 | Metoprolol Succinate | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 1000 | 12 | |
| 0378-4597-77 | Metoprolol Succinate | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 90 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-4597-10 | EA - Each | 0378-4597 | 770fee51-55aa-469a-a405-caa74865e489 | 1 | 2012-07-24 |
| 0378-4597-77 | EA - Each | 0378-4597 | 987d5c3d-6ccb-46b9-8f85-5a65d6e42b6c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0378-4597-10 | 00378459710 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4597-10) | 2019-01-02 | 0000-00-00 | No | No | Current |
| 0378-4597-77 | 00378459777 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4597-77) | 2019-01-02 | 0000-00-00 | No | No | Current |