METOPROLOL TARTRATE

Product NDC
71335-2789
Requested package NDC
71335-2789-8
11-digit product format
713352789
Labeler code
71335
Product ID
71335-2789_b033fa24-c823-44d0-9dda-1ca2a223fb2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200981
Marketing category
ANDA
Marketing start
2024-07-26
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
A200981-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-28
A200981-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-28
A200981-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-28
A200981-004METOPROLOL TARTRATEMETOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-21
A200981-005METOPROLOL TARTRATEMETOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200981-001AB
A200981-002AB
A200981-003AB
A200981-004AB
A200981-005AB

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 · 211 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-2884e616aacf4f…
2026-09-14 22:38:342026-08A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-2184e616aacf4f…
2026-09-14 22:38:342026-08A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-28caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-21caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-001METOPROLOL TARTRATE25MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-002METOPROLOL TARTRATE50MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-003METOPROLOL TARTRATE100MGTABLET / ORALAB2014-10-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2019-08-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-005METOPROLOL TARTRATE75MGTABLET / ORALAB2019-08-2103ed91905a0d…

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 22:38:342026-08A200981-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A200981-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A200981-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A200981-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A200981-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A200981-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200981-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200981-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200981-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200981-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200981-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200981-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200981-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200981-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200981-005AB103ed91905a0d…

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
77fb1898-871f-489f-bc0b-933dd08a9bc4Available 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
71335-2789-1METOPROLOL TARTRATE30 in 1 BOTTLETABLET301
71335-2789-2METOPROLOL TARTRATE60 in 1 BOTTLETABLET601
71335-2789-3METOPROLOL TARTRATE90 in 1 BOTTLETABLET901
71335-2789-4METOPROLOL TARTRATE180 in 1 BOTTLETABLET1801
71335-2789-5METOPROLOL TARTRATE100 in 1 BOTTLETABLET1001
71335-2789-6METOPROLOL TARTRATE120 in 1 BOTTLETABLET1201
71335-2789-7METOPROLOL TARTRATE20 in 1 BOTTLETABLET201
71335-2789-8METOPROLOL TARTRATE10 in 1 BOTTLETABLET101

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 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.0ca72c89-82c5-4b31-b515-1a8b8e82ec592026-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.621249c4-531b-4138-9bde-77a06ad7816b2026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATERedpharm Drug59ed1885-cc00-5325-e063-6294a90a50c22026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.58239cf1-53b4-4ef7-e063-6394a90a65bd2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEProficient Rx LP4871791a-7679-4345-8fd6-fdb9c92173522026-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLC5476c4fc-ab09-ee1a-e063-6394a90a7a1b2026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEBryant Ranch Prepacka590edb1-3310-49e3-b3d1-dbbb3f81f1c12026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATESt. Mary's Medical Park Pharmacy3bc7d371-6057-a9dc-e063-6394a90a6a9c2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals Inc.5fd16fbd-be05-49aa-86a9-0f775c1b5a372026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals Inc.9af11192-61fa-44b8-86eb-3a5e68ec17472026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals, Inc.b4d1e5ba-f1a8-4c77-bd65-db8e9342370b2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATESt. Mary's Medical Park Pharmacye3de73ee-bcc7-ba40-e053-2a95a90a8f8f2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals Inc.35922e9c-6a4c-446a-8294-a4cd3f3f0d102026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLC54754388-39c9-9a02-e063-6394a90a90b32026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLC5466243e-1e3d-175e-e063-6394a90a5dee2026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.fae7a662-9b27-4c5f-80b5-22442f0ae4362026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.5987a15b-e86f-4fd7-a377-35a917c0e3fe2026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
Metoprolol TartrateMETOPROLOL TARTRATEDirect_Rx5371c1af-93fa-39db-e063-6394a90a61112026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATESt. Mary's Medical Park Pharmacye55cd5b5-c739-24ba-e053-2995a90a3ed42026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.f7a05d74-f5e9-4236-a967-c57942a2bbf32026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200981
application number: ANDA200981

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866924metoprolol tartrate 25 MG Oral TabletPSN77fb1898-871f-489f-bc0b-933dd08a9bc41
866924metoprolol tartrate 25 MG Oral TabletSCD77fb1898-871f-489f-bc0b-933dd08a9bc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2789-87133527890810 TABLET in 1 BOTTLE (71335-2789-8) 10 tablet2026-03-11NoNoCurrent