Metoprolol Tartrate

Product NDC
0378-4593
11-digit product format
003784593
Labeler code
0378
Product ID
0378-4593_57d60035-d408-4f98-932e-2cbbeae5326c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076704
Marketing category
ANDA
Marketing start
2016-03-29
Substance
METOPROLOL TARTRATE
Active strength
37.5 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076704-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-16
A076704-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-16
A076704-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-16
A076704-004METOPROLOL TARTRATEMETOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-18
A076704-005METOPROLOL TARTRATEMETOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A076704-001AB
A076704-002AB
A076704-003AB
A076704-004AB
A076704-005AB

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-16caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-18caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-182680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 206 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076704-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076704-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076704-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076704-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076704-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076704-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076704-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076704-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076704-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076704-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076704-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W5S57Y3A5LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866511Internal RxNorm lookup
866514Internal RxNorm lookup
866924Internal RxNorm lookup
1606347Internal RxNorm lookup
1606349Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
809c6386-0039-42ff-a03e-e42733e229b8Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4593-01Metoprolol Tartrate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10031

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4593-01EA - Each0378-45933c89dbd8-23db-4042-8552-f7b388e8161612016-04-04
0378-4593-05EA - Each0378-45935a60c7a2-caef-46ca-a6a0-98b16ba4153012016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4593METOPROLOL TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 1 package rows20240302_809c6386-0039-42ff-a03e-e42733e229b8.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.cbcec1e7-7eac-456e-a253-aaf6761b48832026-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATECardinal Health 107, LLC6399f2c3-7799-4f8b-b8b7-8d2137b1f8522026-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATECardinal Health 107, LLC0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATESafecor Health, LLC63d45147-9b37-40e2-9619-cd1a3e77ff312026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.ab44f4c5-9497-4c92-8545-e4718ddb8f082026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATEMylan Institutional Inc.961248d5-d53c-408d-8f8f-d31885054f962025-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATEGolden State Medical Supply, Inc.bec7ccad-00ad-4a3b-e053-2995a90ae3d82024-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
Metoprolol TartrateMETOPROLOL TARTRATEMylan Pharmaceuticals Inc.809c6386-0039-42ff-a03e-e42733e229b82024-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
ndc (product): 0378-4593
Metoprolol TartrateMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLCea141b60-b08e-4f0f-9f29-cd765f4d7ca62022-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletPSN809c6386-0039-42ff-a03e-e42733e229b831
866511metoprolol tartrate 100 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866924metoprolol tartrate 25 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606347metoprolol tartrate 37.5 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
866514metoprolol tartrate 50 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831
1606349metoprolol tartrate 75 MG Oral TabletSCD809c6386-0039-42ff-a03e-e42733e229b831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-4593-0100378459301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4593-01) 2016-03-290000-00-00NoNoCurrent