Metoprolol Succinate

Product NDC
70518-3545
Requested package NDC
70518-3545-0
11-digit product format
705183545
Labeler code
70518
Product ID
70518-3545_e9eaf557-d6b7-3752-e053-2a95a90a5907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203699
Marketing category
ANDA
Marketing start
2022-09-30
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
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 packagepackage70518-354570518-3545-0DDiscontinued by firm2026-09-14

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 packagepackage70518-354570518-3545-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203699-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30
A203699-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203699-001AB
A203699-002AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203699-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203699-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203699-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203699-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203699-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203699-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203699-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203699-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203699-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203699-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203699-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203699-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203699-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203699-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203699-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203699-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203699-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203699-002AB1bb7c543d1eb4…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3545METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]4Legacy NDC20240326_56fa7b11-e67a-45e1-be5f-2e81fa679947.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3545-07051835450030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-3545-0) 2022-09-300000-00-00NoNoCurrent