Metoprolol Tartrate

Product NDC
67046-469
Requested package NDC
67046-469-15
11-digit product format
670460469
Labeler code
67046
Product ID
67046-469_7e2b1ee0-b04a-f7c6-e053-2991aa0a47ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA076704
Marketing category
ANDA
Marketing start
2017-10-04
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage67046-46967046-469-15IInactivated by FDA2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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.

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-469-07Metoprolol Tartrate7 in 1 BLISTER PACKTABLET, FILM COATED72
67046-469-14Metoprolol Tartrate14 in 1 BLISTER PACKTABLET, FILM COATED142
67046-469-15Metoprolol Tartrate15 in 1 BLISTER PACKTABLET, FILM COATED152
67046-469-20Metoprolol Tartrate20 in 1 BLISTER PACKTABLET, FILM COATED202
67046-469-21Metoprolol Tartrate21 in 1 BLISTER PACKTABLET, FILM COATED212
67046-469-28Metoprolol Tartrate28 in 1 BLISTER PACKTABLET, FILM COATED282
67046-469-30Metoprolol Tartrate30 in 1 BLISTER PACKTABLET, FILM COATED302
67046-469-60Metoprolol Tartrate60 in 1 BLISTER PACKTABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-469METOPROLOL TARTRATE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]2Legacy NDC, 8 package rows20181230_5ab92993-5bc0-20f6-e053-2991aa0aa877.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN5ab92993-5bc0-20f6-e053-2991aa0aa8772
866514metoprolol tartrate 50 MG Oral TabletSCD5ab92993-5bc0-20f6-e053-2991aa0aa8772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-469-156704604691515 TABLET, FILM COATED in 1 BLISTER PACK (67046-469-15) 2017-10-040000-00-00NoNoCurrent