METOPROLOL TARTRATE

Product NDC
0615-8422
11-digit product format
006158422
Labeler code
0615
Product ID
0615-8422_d1fcc391-6fd0-4240-b53d-83262763d0e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202871
Marketing category
ANDA
Marketing start
2016-07-31
Substance
METOPROLOL TARTRATE
Active strength
50 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0615-84220615-8422-30DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-84220615-8422-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202871-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28
A202871-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28
A202871-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202871-001AB
A202871-002AB
A202871-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-002METOPROLOL TARTRATE50MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-003METOPROLOL TARTRATE100MGTABLET / ORALAB2013-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202871-001METOPROLOL TARTRATE25MGTABLET / ORALAB2013-05-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202871-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202871-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202871-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202871-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202871-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202871-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202871-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202871-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202871-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202871-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202871-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202871-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202871-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202871-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202871-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202871-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202871-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202871-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
METOPROLOL TARTRATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE50 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
c97e7527-b44e-48ca-b6be-53999bf5554bAvailable 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
95ced987-af5e-4bea-8119-4e7d4558d21bProduct name220200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
9ab5a42a-e77d-486b-bb1f-b343fe664adaProduct name120180430
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
310125de-e7c0-730d-d178-98b990a0334aProduct name220150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8422-05METOPROLOL TARTRATE15 in 1 BLISTER PACKTABLET1511
0615-8422-30METOPROLOL TARTRATE6 in 1 BOX, UNIT-DOSETABLET611
0615-8422-30METOPROLOL TARTRATE5 in 1 BLISTER PACKTABLET511
0615-8422-39METOPROLOL TARTRATE30 in 1 BLISTER PACKTABLET3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8422METOPROLOL TARTRATE (METOPROLOL) TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]8Current NDC, Legacy NDC, 4 package rows20240925_c97e7527-b44e-48ca-b6be-53999bf5554b.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.58d493d3-b69c-422a-b6a8-0f8fa1e555452026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLBryant Ranch Prepack00940cc5-d2eb-4841-9138-de97d7b1c6742026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNorthwind Health Company, LLC471ccbfe-96dd-7ab9-e063-6394a90a5bd62026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.e1c99d45-8f42-46b1-b770-14d0eb2b300a2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLCoupler LLC512711ea-a3be-6de6-e063-6394a90a91092026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLProficient Rx LP95b95aab-0733-4189-b4c0-429a1046c5342026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNuCare Pharmaceuticals, Inc.47d11c0c-82dd-33b1-e063-6394a90a6a972026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNorthwind Health Company, LLC106b7a0c-af7f-2565-e063-6294a90a34e02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLNCS HealthCare of KY, LLC dba Vangard Labsc97e7527-b44e-48ca-b6be-53999bf5554b2025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
ndc (product): 0615-8422
METOPROLOL TARTRATEMETOPROLOLAlembic Pharmaceuticals Inc.24837d82-0f3f-4482-9af0-31e5f675c30f2024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871
METOPROLOL TARTRATEMETOPROLOLAlembic Pharmaceuticals Limitedcb76a73f-549a-4170-b96a-f93ed7e094642023-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202871
application number: ANDA202871

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866511metoprolol tartrate 100 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866924metoprolol tartrate 25 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866514metoprolol tartrate 50 MG Oral TabletPSNc97e7527-b44e-48ca-b6be-53999bf5554b11
866511metoprolol tartrate 100 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11
866924metoprolol tartrate 25 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11
866514metoprolol tartrate 50 MG Oral TabletSCDc97e7527-b44e-48ca-b6be-53999bf5554b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8422-050061584220515 TABLET in 1 BLISTER PACK (0615-8422-05) 15 tablet2022-02-080000-00-00NoNoCurrent
0615-8422-30006158422306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8422-30) > 5 TABLET in 1 BLISTER PACK6 blister pack2022-02-090000-00-00NoNoCurrent
0615-8422-390061584223930 TABLET in 1 BLISTER PACK (0615-8422-39) 30 tablet2022-02-080000-00-00NoNoCurrent