Application 076704

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL25MGNoNo
002METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL50MGNoNo
003METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL100MGNoYes
004METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL37.5MGNoNo
005METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL75MGNoNo

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…

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
ndc (product): 55154-5512
ndc (product): 55154-5356
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 (product): 55289-382
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 (product): 71610-556
ndc (product): 71610-559
ndc (product): 71610-565

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 132 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55154-5356Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55154-5512Metoprolol Tartratemetoprolol tartrateCardinal HealthANDACurrent
55289-382Metoprolol Tartratemetoprolol tartratePD-Rx Pharmaceuticals, InANDACurrent
55289-382Metoprolol Tartratemetoprolol tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-382Metoprolol Tartratemetoprolol tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-382Metoprolol Tartratemetoprolol tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-382Metoprolol Tartratemetoprolol tartratePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-212Metoprolol Tartratemetoprolol tartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
58517-320METOPROLOL TARTRATEMETOPROLOL TARTRATENew Horizon Rx Group, LLCANDACurrent
61919-726METOPROLOL TARTRATEMETOPROLOL TARTRATEDIRECT RXANDACurrent
61919-726METOPROLOL TARTRATEMETOPROLOL TARTRATEDirect_RxANDACurrent
61919-726METOPROLOL TARTRATEMETOPROLOL TARTRATEDirect_RxANDACurrent
67046-469Metoprolol Tartratemetoprolol tartrateContract Pharmacy Services-PAANDACurrent
67046-472Metoprolol Tartratemetoprolol tartrateContract Pharmacy Services-PAANDACurrent
67296-0701Metoprolol Tartratemetoprolol tartrateRedPharm DrugANDACurrent
67296-0701Metoprolol Tartratemetoprolol tartrateRedPharm DrugANDACurrent
67544-567Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-627Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-911Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-7338Metoprolol Tartratemetoprolol tartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7338Metoprolol Tartratemetoprolol tartratePreferred Pharmaceuticals Inc.ANDACurrent
68788-7338Metoprolol Tartratemetoprolol tartratePreferred Pharmaceuticals Inc.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0381Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0877Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-0877Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1354Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1354Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1354Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1354Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1354Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1872Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
70518-1872Metoprolol Tartratemetoprolol tartrateREMEDYREPACK INC.ANDACurrent
71610-556Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-556Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-559Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-559Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-565Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-565Metoprolol Tartratemetoprolol tartrateAphena Pharma Solutions - Tennessee, LLCANDACurrent