Metoprolol Succinate

Product NDC
60760-616
Requested package NDC
60760-616-90
11-digit product format
607600616
Labeler code
60760
Product ID
60760-616_7ad086e3-91fe-fcb7-e053-2a91aa0acdfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA204106
Marketing category
ANDA
Marketing start
2018-08-21
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
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60760-61660760-616-90DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-616-90EA - Each60760-616cfb4fcdd-8fe9-4b92-9d47-854d96a90d3d12018-10-11

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-616-906076006169090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (60760-616-90) 2018-08-210000-00-00NoNoCurrent