Metoprolol Succinate

Product NDC
71610-573
Requested package NDC
71610-573-60
11-digit product format
716100573
Labeler code
71610
Product ID
71610-573_94dbe4d4-48d3-41da-bcdf-ffac7505d0ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204106
Marketing category
ANDA
Marketing start
2018-02-06
Substance
METOPROLOL SUCCINATE
Active strength
200 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
A204106-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06
A204106-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06
A204106-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06
A204106-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A204106-001AB
A204106-002AB
A204106-003AB
A204106-004AB

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 UTC2026-02A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204106-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2018-02-06d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204106-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204106-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204106-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204106-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204106-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204106-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204106-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204106-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204106-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204106-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204106-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204106-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204106-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL SUCCINATE200 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866419Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf5ea3bc-91c9-40f4-be82-b37d4098dfd2Available 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
71610-573-45Metoprolol Succinate45 in 1 BOTTLETABLET, EXTENDED RELEASE451
71610-573-60Metoprolol Succinate90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-573-45EA - Each71610-573a795db87-d6a4-4230-8291-33ece9fa3ce612021-09-07
71610-573-60EA - Each71610-573a5058929-a0e7-43c2-9c54-752a4e3c90d812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-573METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 2 package rows20210803_cf5ea3bc-91c9-40f4-be82-b37d4098dfd2.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol SuccinateMETOPROLOL SUCCINATECoupler LLC55f47fad-ddc9-d9e6-e063-6394a90a48cf2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEGolden State Medical Supply, Inc.bd0b68cc-3a7e-2223-e053-2995a90ac8f62026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEIngenus Pharmaceuticals, LLC9dcd1fdf-a651-48d4-8033-e5749d5f56502026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEPD-Rx Pharmaceuticals, Inc.ff3eaf6a-5697-4ad9-98c4-86925e6da2572026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATENorthwind Health Company, LLCc213c327-68b7-da5b-e053-2a95a90a40282026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEBluePoint Laboratories99ecc717-38ab-4d00-8bf2-86a41b1c79772025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
METOPROLOL SUCCINATE ERMETOPROLOL SUCCINATEDirect_Rx7ea78d2a-aa9f-38d4-e053-2991aa0a07fe2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LP58d0fe08-f965-41cb-9592-fde060092b7e2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LP1806dadd-9ebb-46ee-9b86-f153e6db3b482022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLCba2dc4ad-0f3f-4c21-9daf-29a79657aa9f2022-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLCcf5ea3bc-91c9-40f4-be82-b37d4098dfd22021-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
ndc (package): 71610-573-60
ndc (product): 71610-573
ndc11 (package): 71610057360
Metoprolol SuccinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLC26d1762f-b70c-40b2-a9c7-c855cb5b14d52021-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LP25d7926c-061f-4eb0-8d30-6397efeca16d2020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204106
application number: ANDA204106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNcf5ea3bc-91c9-40f4-be82-b37d4098dfd21
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDcf5ea3bc-91c9-40f4-be82-b37d4098dfd21
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYcf5ea3bc-91c9-40f4-be82-b37d4098dfd21
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYcf5ea3bc-91c9-40f4-be82-b37d4098dfd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-573-607161005736090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-573-60) 2021-06-250000-00-00NoNoCurrent