Metoprolol Succinate

Product NDC
55700-976
Requested package NDC
55700-976-90
11-digit product format
557000976
Labeler code
55700
Product ID
55700-976_98d17cab-7ebb-44c4-8497-b3f53d9823aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate ER Tablets
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA211143
Marketing category
ANDA
Marketing start
2022-07-19
Marketing end
0000-00-00
Substance
METOPROLOL SUCCINATE
Active strength
25 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-97655700-976-90DDiscontinued by firm2026-08-10

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-97655700-976-90DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A211143-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25
A211143-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25
A211143-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25
A211143-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211143-001AB
A211143-002AB
A211143-003AB
A211143-004AB

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 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211143-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-11-25d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211143-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211143-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211143-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211143-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211143-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211143-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211143-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211143-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211143-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211143-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211143-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211143-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211143-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-976-90EA - Each55700-9761b6d72f1-76af-46ae-b8fb-51e633013df512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-976METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]3Legacy NDC20241222_268937b1-af14-48e7-b84e-724d86db4b7a.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSREMEDYREPACK INC.76c69d7c-e90c-4f96-a45b-e9dad94442632026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBluePoint Laboratories6588d77c-090f-4722-9c91-437887d4624a2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSREMEDYREPACK INC.28c22fb6-6cc9-4c41-b781-88b33b6c8cee2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack05d8ebd3-d6ad-434c-8788-985d50a2abfd2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack38429f45-5dc7-4455-840c-dee48f60d95b2025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSProficient Rx LP33d39ddc-478a-4d98-80d1-f655202192ae2025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSAscend Laboratories, LLC58441cd3-6043-4bb8-adab-1b32a203bfb22025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepacke602c70f-9ea3-480f-a7df-15f23c6b33072025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack28ca1918-c220-41b3-9e58-a0a023f775d02025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack8ed15c20-23a2-40ba-95e8-2689d182a52f2025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack01908d20-0e16-4410-bd27-1b6df162ede42025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack89e642f6-5f8c-4352-8da6-7b74ed4ff23c2025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack8d812b11-c9ec-470e-a108-70d86403e4732025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack2ef668c8-7279-4f61-b6af-9c4ccb3b90d02025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepackdbb4cadc-5af0-4ff5-ab6c-8bf1b68b700c2025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepackafa6c1f5-0c8e-496f-930a-1ade1f69646b2025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack123f2051-4bff-4621-aaba-65f54f4e77842025-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepackd1bbf535-8b02-4d99-bb4d-2e87454c1d612025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack52496331-174e-4ae3-9763-6b9a4072befd2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepackef628c06-756b-4f17-9960-439eaf7154442024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211143
application number: ANDA211143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-976-905570009769090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55700-976-90) 2022-07-190000-00-00NoNoCurrent