FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
71610-556
Requested package NDC
71610-556-92
11-digit product format
716100556
Labeler code
71610
Product ID
71610-556_4b804930-cb3d-41eb-b76f-afaff44ba395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076704
Marketing category
ANDA
Marketing start
2004-01-16
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
2026-12-31
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
2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866511Internal RxNorm lookup
866514Internal RxNorm lookup
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
ea141b60-b08e-4f0f-9f29-cd765f4d7ca6Available 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
71610-556-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
71610-556-45Metoprolol Tartrate45 in 1 BOTTLE, PLASTICTABLET, FILM COATED452
71610-556-53Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
71610-556-60Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
71610-556-70Metoprolol Tartrate120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
71610-556-80Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1802
71610-556-92Metoprolol Tartrate270 in 1 BOTTLE, PLASTICTABLET, FILM COATED2702
71610-556-98Metoprolol Tartrate540 in 1 BOTTLE, PLASTICTABLET, FILM COATED5402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-556-30EA - Each71610-556ac96fedb-4595-4950-a89c-2271d295ac2c12021-08-05
71610-556-45EA - Each71610-556d62a16c7-30a0-4813-ba46-c5423cf8d14912022-05-04
71610-556-53EA - Each71610-556ed4c6540-e3f5-4fa8-8c18-3ced459c202e12021-08-05
71610-556-60EA - Each71610-556377375fc-6d5d-41df-b431-5a673138075812021-08-05
71610-556-70EA - Each71610-5568676a238-b18e-41d9-9a3f-26bbb660b49c12021-08-05
71610-556-80EA - Each71610-5564c3e4175-f8fa-4a42-bf2b-6c1ed35f131a12021-08-05
71610-556-92EA - Each71610-556148ae24d-56ca-4865-bf31-a81207f0354612021-08-05
71610-556-98EA - Each71610-5563ecea3f4-a1d8-4664-83e6-f4b9ea77f08a12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-556METOPROLOL TARTRATE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 8 package rows20220311_ea141b60-b08e-4f0f-9f29-cd765f4d7ca6.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
Metoprolol TartrateMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLCea141b60-b08e-4f0f-9f29-cd765f4d7ca62022-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076704
application number: ANDA076704
ndc (package): 71610-556-92
ndc (product): 71610-556
ndc11 (package): 71610055692

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNea141b60-b08e-4f0f-9f29-cd765f4d7ca62
866924metoprolol tartrate 25 MG Oral TabletPSNea141b60-b08e-4f0f-9f29-cd765f4d7ca62
866514metoprolol tartrate 50 MG Oral TabletPSNea141b60-b08e-4f0f-9f29-cd765f4d7ca62
866511metoprolol tartrate 100 MG Oral TabletSCDea141b60-b08e-4f0f-9f29-cd765f4d7ca62
866924metoprolol tartrate 25 MG Oral TabletSCDea141b60-b08e-4f0f-9f29-cd765f4d7ca62
866514metoprolol tartrate 50 MG Oral TabletSCDea141b60-b08e-4f0f-9f29-cd765f4d7ca62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-556-9271610055692270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-556-92) 2021-05-190000-00-00NoNoCurrent