METOPROLOL SUCCINATE

Product NDC
50816-200
11-digit product format
508160200
Labeler code
50816
Product ID
50816-200_e4cd6ed2-e776-32d1-e053-2a95a90aa8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
New American Therapeutics
Application
NDA019962
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-01
Marketing end
0000-00-00
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50816-200IInactivated by FDA2026-08-10
excluded packagepackage50816-20050816-200-02IInactivated by FDA2026-08-10
excluded packagepackage50816-20050816-200-03IInactivated by FDA2026-08-10

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 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50816-200-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50816-200-03IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50816-200-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50816-200-03IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50816-200-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50816-200-03IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50816-200-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50816-200-03IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50816-200-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50816-200-03IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50816-200-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50816-200-03IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50816-200-02UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50816-200-03UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50816-200-02UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50816-200-03UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50816-200-02UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50816-200-03UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50816-200-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50816-200-03IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50816-200-02IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50816-200-03IInactivated 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019962-001TOPROL-XLMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10
N019962-002TOPROL-XLMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10
N019962-003TOPROL-XLMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10
N019962-004TOPROL-XLMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019962-001AB
N019962-002AB
N019962-003AB
N019962-004AB

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 UTC2026-02N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019962-001TOPROL-XLEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-002TOPROL-XLEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD1992-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-003TOPROL-XLEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD, RS1992-01-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-004TOPROL-XLEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALABRLD2001-02-05d06236e962d9…

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 UTC2026-02N019962-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019962-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019962-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019962-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019962-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019962-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019962-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019962-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019962-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019962-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019962-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019962-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019962-004AB1d06236e962d9…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50816-200-022025-01-30These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032025-01-30These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-022022-05-17These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032022-05-17These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-022022-01-28These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006
50816-200-032022-01-28These highlights do not include all the information needed to use Metoprolol Succinate safely and effectively. See full prescribing information for Metoprolol Succinate. Metoprolol Succinate Tablet, Extended-Release for Oral Use Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50816-200-02METOPROLOL SUCCINATE100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
50816-200-03METOPROLOL SUCCINATE1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50816-200METOPROLOL SUCCINATE TABLET, EXTENDED RELEASE [NEW AMERICAN THERAPEUTICS]9Legacy NDC, 2 package rows20230425_d66c1b47-e67f-4b5c-9290-f90bbb378971.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOPROL XLMETOPROLOL SUCCINATEMelinta Therapeutics, LLC496ddfaa-7c9c-4888-b747-a210249b367a2026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEProficient Rx LPe236f1ed-b400-4854-81c7-64964422a2f72019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962
TOPROL XLMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLCa07891a5-152e-4a38-8179-e05a90458a7d2018-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 019962
application number: NDA019962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866412metoprolol succinate 100 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866427metoprolol succinate 25 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
866436metoprolol succinate 50 MG 24HR Extended Release Oral TabletPSNd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641224 HR metoprolol succinate 100 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86642724 HR metoprolol succinate 25 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86643624 HR metoprolol succinate 50 MG Extended Release Oral TabletSCDd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641224 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86642724 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
86643624 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866412metoprolol succinate 100 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866427metoprolol succinate 25 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866436metoprolol succinate 50 MG 24 HR Extended Release Oral TabletSYd66c1b47-e67f-4b5c-9290-f90bbb3789719
866419metoprolol succinate 200 MG 24HR Extended Release Oral TabletPSN1e487de1-848a-4ee8-929b-406dac3791661
86641924 HR metoprolol succinate 200 MG Extended Release Oral TabletSCD1e487de1-848a-4ee8-929b-406dac3791661
86641924 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral TabletSY1e487de1-848a-4ee8-929b-406dac3791661
866419metoprolol succinate 200 MG 24 HR Extended Release Oral TabletSY1e487de1-848a-4ee8-929b-406dac3791661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50816-200-025081602000212 BOTTLE in 1 PACKAGE (50816-200-02) > 100 TABLET, EXTENDED RELEASE in 1 BOTTLE12 bottle2020-08-310000-00-00NoNoCurrent
50816-200-03508160200036 BOTTLE in 1 PACKAGE (50816-200-03) > 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE6 bottle2020-08-310000-00-00NoNoCurrent