Metoprolol Tartrate

Product NDC
55289-382
Requested package NDC
55289-382-30
11-digit product format
552890382
Labeler code
55289
Product ID
55289-382_525a6d19-36b4-ca74-e063-6294a90a03cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076704
Marketing category
ANDA
Marketing start
2004-02-23
Substance
METOPROLOL TARTRATE
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076704-001METOPROLOL TARTRATE25MGTABLET / ORALAB2004-01-1684e616aacf4f…
2026-09-14 22:38:342026-08A076704-002METOPROLOL TARTRATE50MGTABLET / ORALAB2004-01-1684e616aacf4f…
2026-09-14 22:38:342026-08A076704-003METOPROLOL TARTRATE100MGTABLET / ORALABRS2004-01-1684e616aacf4f…
2026-09-14 22:38:342026-08A076704-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2015-03-1884e616aacf4f…
2026-09-14 22:38:342026-08A076704-005METOPROLOL TARTRATE75MGTABLET / ORALAB2015-03-1884e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 211 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076704-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076704-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076704-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A076704-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A076704-005AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE25 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866924Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab44f4c5-9497-4c92-8545-e4718ddb8f08Available 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
55289-382-14Metoprolol Tartrate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1419
55289-382-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3019
55289-382-60Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6019
55289-382-90Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9019
55289-382-93Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-382-14EA - Each55289-382450f3017-ffa9-4a39-8d30-8a13e87b269b12017-06-15
55289-382-30EA - Each55289-38253b2b589-3baa-49c5-ae8c-3bf6729b9dc312012-07-24
55289-382-60EA - Each55289-38273de424c-7d55-4793-b749-f4a7b6bc2ea212026-05-22
55289-382-90EA - Each55289-382095c14f8-71a8-4a21-a4a4-7b54b2ac4f1012015-05-05
55289-382-93EA - Each55289-3827a6f2fe1-400c-478d-a8b5-a13780a0738f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMETOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-382METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 5 package rows20240314_ab44f4c5-9497-4c92-8545-e4718ddb8f08.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
ndc (package): 55289-382-30
ndc (product): 55289-382
ndc11 (package): 55289038230
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
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
866924metoprolol tartrate 25 MG Oral TabletPSNab44f4c5-9497-4c92-8545-e4718ddb8f0819
866924metoprolol tartrate 25 MG Oral TabletSCDab44f4c5-9497-4c92-8545-e4718ddb8f0819

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-382-305528903823030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-382-30) 2012-05-020000-00-00NoNoCurrent