Metoprolol succinate

Product NDC
70934-319
Requested package NDC
70934-319-30
11-digit product format
709340319
Labeler code
70934
Product ID
70934-319_af4c69ac-320f-5496-e053-2995a90a48a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA078889
Marketing category
ANDA
Marketing start
2019-03-18
Marketing end
0000-00-00
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
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 packagepackage70934-31970934-319-30DDiscontinued by firm2026-08-03

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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

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

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
A078889-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15
A078889-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078889-001AB
A078889-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078889-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A078889-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2012-08-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078889-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078889-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078889-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078889-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078889-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078889-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078889-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078889-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078889-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078889-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078889-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078889-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078889-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078889-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078889-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078889-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078889-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078889-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078889-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078889-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078889-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078889-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078889-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078889-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078889-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078889-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078889-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078889-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078889-002AB1782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

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 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLC52bdc5cc-973f-4af6-e063-6294a90aba222026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol SuccinateMETOPROLOL SUCCINATECardinal Health 107, LLC450fb603-73d7-422b-a4e2-5a05c13ebe3b2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack7689f30e-4010-4d7f-b450-9bc1812594952026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack860e0ee0-b24f-4eff-b196-b9b03b37d3d52026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Inc5b7095c8-f8b7-adc7-9052-92325da33a022026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.d971e541-3988-4834-baa2-236133ee106f2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEPD-Rx Pharmaceuticals, Inc.189b6a89-8de8-4a62-a54b-a6c52be870ca2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack5d553160-7fcb-413a-8775-c128a18449772025-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEAvPAK71b27b55-44aa-113d-e053-2995a90a1cf72025-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATECardinal Health 107, LLC184db12c-0642-4741-a997-cd0b2a5ce3372025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEMajor Pharmaceuticals459fe5ce-14d1-4901-956a-b5597ea9016c2025-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Limited71c1d33e-be6f-6d59-b715-45075445891a2025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEQuallent Pharmaceuticals Health LLCe147a897-4a23-1e1a-73cd-f2e6c9a7280d2025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATENorthstar Rx LLCd887be8a-e6c2-5129-edbd-d7b2c0283dca2025-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.35304060-0965-488d-9e6e-bd1217286ea12025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATENCS HealthCare of KY, LLC dba Vangard Labs53613463-d5b6-41e7-aa43-1b75633c61fd2024-09-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol SuccinateMETOPROLOL SUCCINATEAmerican Health Packaging74e3b4dc-eb30-4d7c-a558-cf58f64704962024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionsaa1c7d31-78be-465f-9564-03685a58add82024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionsf09d07f1-e0d1-444d-8e8a-f340f7377c8d2024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEDirect_Rx90a69a79-5517-0ccf-e053-2995a90a441f2024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078889
application number: ANDA078889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-319-307093403193030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-319-30) 2019-09-110000-00-00NoNoCurrent