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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-4597DDiscontinued by firm2026-10-15
excluded packagepackage0378-45970378-4597-10DDiscontinued by firm2026-10-15
excluded packagepackage0378-45970378-4597-77DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202033-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15
A202033-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15
A202033-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15
A202033-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15

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.

Product history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15c2088c7a36db…
2026-10-15 13:18:302026-09A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15c2088c7a36db…
2026-10-15 13:18:302026-09A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15c2088c7a36db…
2026-10-15 13:18:302026-09A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15c2088c7a36db…
2026-09-14 22:38:342026-08A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-1584e616aacf4f…
2026-09-14 22:38:342026-08A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-1584e616aacf4f…
2026-08-18 06:07:402026-07A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORAL2011-12-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202033-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202033-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202033-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202033-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2011-12-152680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202033-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202033-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202033-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202033-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202033-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202033-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202033-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202033-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202033-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202033-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202033-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202033-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202033-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202033-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202033-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202033-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202033-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202033-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202033-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202033-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202033-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202033-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202033-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202033-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202033-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202033-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202033-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202033-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202033-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202033-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202033-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202033-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202033-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202033-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202033-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202033-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202033-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202033-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202033-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202033-004AB1782e0a99824c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4fProduct name120260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
07ea0487-5434-6896-2497-013a7ee4afbdProduct name920250311
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4597-10Metoprolol Succinate1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE100012
0378-4597-77Metoprolol Succinate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4597-10EA - Each0378-4597770fee51-55aa-469a-a405-caa74865e48912012-07-24
0378-4597-77EA - Each0378-4597987d5c3d-6ccb-46b9-8f85-5a65d6e42b6c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]5
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4597METOPROLOL SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]11Legacy NDC, 2 package rows20250116_c50e8e36-42df-406b-8e63-eb8bf3f07e89.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4597-10003784597101000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4597-10) 2019-01-020000-00-00NoNoCurrent
0378-4597-770037845977790 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4597-77) 2019-01-020000-00-00NoNoCurrent