Metoprolol succinate

Product NDC
68645-478
11-digit product format
686450478
Labeler code
68645
Product ID
68645-478_dabd02a6-6444-1bdc-e053-2a95a90a9668
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA090617
Marketing category
ANDA
Marketing start
2012-09-10
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68645-478DDiscontinued by firm2026-10-05
excluded packagepackage68645-47868645-478-54DDiscontinued by firm2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090617-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01
A090617-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090617-001AB
A090617-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0184e616aacf4f…
2026-09-14 22:38:342026-08A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0184e616aacf4f…
2026-08-18 06:07:402026-07A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01caaa826d4ba7…
2026-08-18 06:07:402026-07A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090617-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090617-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-0174a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090617-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090617-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090617-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090617-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090617-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090617-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090617-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090617-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090617-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090617-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090617-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090617-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090617-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090617-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090617-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090617-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090617-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090617-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090617-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090617-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090617-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090617-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090617-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090617-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090617-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090617-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090617-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090617-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090617-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090617-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090617-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090617-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090617-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090617-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090617-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090617-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090617-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090617-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090617-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090617-002AB174a2ff9319b5…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-478-54EA - Each68645-4786c2f72f7-09d5-43ba-bedb-e3ad2547b23212014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL SUCCINATEACTIVE INGREDIENTTH25PD4CCBMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
ACETYLTRIBUTYL CITRATEINACTIVE INGREDIENT0ZBX0N59RZMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
ETHYLCELLULOSE (10 MPA.S)INACTIVE INGREDIENT3DYK7UYZ62METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EAMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-478METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [LEGACY PHARMACEUTICAL PACKAGING, LLC]12Legacy NDC20241016_98d31d43-eff0-4ba9-9953-f2f53c13b3d9.zip

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.

Matched openFDA labels page 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2024-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090617
application number: ANDA090617
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions836c4a24-42f6-451a-8911-23444e01e5e82024-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090617
application number: ANDA090617
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack42bb324d-8b1e-45db-b15e-3845eec83c382023-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090617
application number: ANDA090617
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Limited90594d68-87f2-5f75-2d8a-1629f88ba8a92023-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090617
application number: ANDA090617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68645-478-546864504785430 TABLET, EXTENDED RELEASE in 1 BOTTLE (68645-478-54) 2012-09-100000-00-00NoNoCurrent