Metoprolol Tartrate

Product NDC
0904-6341
Requested package NDC
0904-6341-80
11-digit product format
009046341
Labeler code
0904
Product ID
0904-6341_1d470f32-a887-4db7-9c82-a71be8ad6263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA202871
Marketing category
ANDA
Marketing start
2014-03-14
Marketing end
0000-00-00
Substance
METOPROLOL TARTRATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage0904-63410904-6341-80DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202871-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28
A202871-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28
A202871-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202871-001AB
A202871-002AB
A202871-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202871-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202871-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202871-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202871-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202871-001AB11e350fbaab3a…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6341-60EA - Each0904-63419498e27f-9406-42db-9ac9-d59fd21fae8a12014-02-04
0904-6341-80EA - Each0904-6341b6f4b6eb-16d0-4a92-aa41-5f4f1e1926d412014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
POVIDONE K12INACTIVE INGREDIENT333AG72FWJMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [MAJOR PHARMACEUTICALS]4
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET [CARDINAL HEALTH]1

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.58d493d3-b69c-422a-b6a8-0f8fa1e555452026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLBryant Ranch Prepack00940cc5-d2eb-4841-9138-de97d7b1c6742026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNorthwind Health Company, LLC471ccbfe-96dd-7ab9-e063-6394a90a5bd62026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.e1c99d45-8f42-46b1-b770-14d0eb2b300a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLCoupler LLC512711ea-a3be-6de6-e063-6394a90a91092026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLProficient Rx LP95b95aab-0733-4189-b4c0-429a1046c5342026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNuCare Pharmaceuticals, Inc.47d11c0c-82dd-33b1-e063-6394a90a6a972026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNorthwind Health Company, LLC106b7a0c-af7f-2565-e063-6294a90a34e02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNCS HealthCare of KY, LLC dba Vangard Labsc97e7527-b44e-48ca-b6be-53999bf5554b2025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLAlembic Pharmaceuticals Inc.24837d82-0f3f-4482-9af0-31e5f675c30f2024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLAlembic Pharmaceuticals Limitedcb76a73f-549a-4170-b96a-f93ed7e094642023-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6341-80009046341801000 TABLET in 1 BOTTLE (0904-6341-80) 1000 tablet2014-03-140000-00-00NoNoCurrent