METOPROLOL SUCCINATE

Product NDC
49884-405
11-digit product format
498840405
Labeler code
49884
Product ID
49884-405_fcca559c-280e-4e44-b70c-6fe89ee3a277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Par Pharmaceutical Inc.
Application
NDA019962
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2007-08-02
Marketing end
2019-10-31
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
0000-00-00
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 productproduct49884-405DDiscontinued by firm2026-08-10
excluded packagepackage49884-40549884-405-01DDiscontinued by firm2026-08-10
excluded packagepackage49884-40549884-405-10DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-405-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-405-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-405-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-405-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-405-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-405-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-405-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-405-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-405-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-405-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-405-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-405-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-405-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-405-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-405-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-405-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-405-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-405-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-405-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-405-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-405-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-405-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-405-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-405-01557ba5c1ecfa…9c80585c8c6e…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-405-01EA - Each49884-40504b32ada-1a78-418d-9953-5928d6a1444012012-07-24
49884-405-10EA - Each49884-4054f18701e-bfe5-4223-9fc7-2357bee8409112012-07-24

DailyMed Socrata Ingredients#

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