Metoprolol Succinate

Product NDC
63304-010
11-digit product format
633040010
Labeler code
63304
Product ID
63304-010_32a6b020-3673-469f-8757-741297fb458b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries Inc.
Application
NDA210428
Marketing category
NDA
Marketing start
2018-02-07
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N210428-001KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-002KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-003KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-004KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210428-00195046552035-07-09Drug product2018-03-14
N210428-00197005302035-07-09Drug product2018-03-14
N210428-00295046552035-07-09Drug product2018-03-14
N210428-00297005302035-07-09Drug product2018-03-14
N210428-00395046552035-07-09Drug product2018-03-14
N210428-00397005302035-07-09Drug product2018-03-14
N210428-00495046552035-07-09Drug product2018-03-14
N210428-00497005302035-07-09Drug product2018-03-14

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210428-00195046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00197005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00295046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00297005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00395046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00397005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00495046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00497005302035-07-09Drug product2018-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00195046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00197005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00295046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00297005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00395046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00397005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00495046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00497005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N210428-00195046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00197005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00295046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00297005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00395046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00397005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00495046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00497005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00195046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00197005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00295046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00297005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00395046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00397005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00495046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00497005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00195046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00197005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00295046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00297005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00395046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00397005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00495046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00497005302035-07-09Drug product2018-03-14b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TH25PD4CCBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1999031Internal RxNorm lookup
1999033Internal RxNorm lookup
1999035Internal RxNorm lookup
1999037Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
90aa06a3-100f-4466-b950-506303707b01Available on FDA.report

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
63304-010-30Metoprolol Succinate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-010METOPROLOL SUCCINATE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES INC.]9Current NDC, Legacy NDC, 1 package rows20180208_90aa06a3-100f-4466-b950-506303707b01.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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KAPSPARGOMETOPROLOL SUCCINATESun Pharmaceutical Industries, Inc.9cfa55b4-15c6-40f7-b6e5-41096ee51bfc2023-04-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 210428
application number: NDA210428
Metoprolol SuccinateMETOPROLOL SUCCINATESun Pharmaceutical Industries Inc.90aa06a3-100f-4466-b950-506303707b012018-02-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 210428
application number: NDA210428
ndc (product): 63304-010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999031metoprolol succinate 100 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999033metoprolol succinate 200 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999035metoprolol succinate 25 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
1999037metoprolol succinate 50 MG 24HR Extended Release Oral CapsulePSN90aa06a3-100f-4466-b950-506303707b019
199903124 HR metoprolol succinate 100 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903324 HR metoprolol succinate 200 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903524 HR metoprolol succinate 25 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
199903724 HR metoprolol succinate 50 MG Extended Release Oral CapsuleSCD90aa06a3-100f-4466-b950-506303707b019
1999031metoprolol succinate 100 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999033metoprolol succinate 200 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999035metoprolol succinate 25 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019
1999037metoprolol succinate 50 MG 24 HR Extended Release Oral CapsuleSY90aa06a3-100f-4466-b950-506303707b019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-010-306330400103030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-010-30) 2018-02-070000-00-00NoNoCurrent