Metoprolol Tartrate

Product NDC
43063-821
11-digit product format
430630821
Labeler code
43063
Product ID
43063-821_47cee106-d10c-fb07-e063-6294a90ac517
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA077739
Marketing category
ANDA
Marketing start
2007-09-11
Marketing end
2027-08-31
Substance
METOPROLOL TARTRATE
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077739-001METOPROLOL TARTRATEMETOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11
A077739-002METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11
A077739-003METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11
A077739-004METOPROLOL TARTRATEMETOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07
A077739-005METOPROLOL TARTRATEMETOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077739-001AB
A077739-002AB
A077739-003AB
A077739-004AB
A077739-005AB

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 4 · 157 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-001METOPROLOL TARTRATE25MGTABLET / ORALAB2007-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-002METOPROLOL TARTRATE50MGTABLET / ORALAB2007-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-003METOPROLOL TARTRATE100MGTABLET / ORALAB2007-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-004METOPROLOL TARTRATE37.5MGTABLET / ORALAB2023-12-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-005METOPROLOL TARTRATE75MGTABLET / ORALAB2023-12-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 157 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077739-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077739-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077739-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077739-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077739-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077739-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077739-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077739-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077739-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077739-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866514Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19678edf-934a-45f3-b5da-94d10e9b3248Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43063-821-30Metoprolol Tartrate30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3030
43063-821-60Metoprolol Tartrate60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6030
43063-821-90Metoprolol Tartrate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9030
43063-821-93Metoprolol Tartrate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-821-30EA - Each43063-821f8deece7-6783-4d3e-ba20-20e07d9e11ab12018-08-13
43063-821-60EA - Each43063-821db593fe6-80e0-44ff-8c6f-25977bd9093c12018-07-03
43063-821-90EA - Each43063-82106a91e35-6e65-4a7a-9990-350b32c22d3f12018-02-20
43063-821-93EA - Each43063-8216ce0a499-da19-449b-83ec-3debe96a764612018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-821METOPROLOL TARTRATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]27Current NDC, Legacy NDC, 4 package rows20240703_19678edf-934a-45f3-b5da-94d10e9b3248.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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.028b6e4a-1597-4d21-89d0-0bbbad21efa82026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEAmerican Health Packaging0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e82026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.ad7a07a1-a05f-4eee-ba0a-69675ffbb6e82026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.3a236293-35c1-4083-9805-ab40df5350832026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.c9ccdbc0-0e4e-40c4-aacf-de60deda9fd52026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATELegacy Pharmaceutical Packaging, LLC20cc66c0-a00b-4643-9819-6e0daed51e5f2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEA-S Medication Solutionse1bb16fa-4f72-44bc-bc33-d7653c13f55c2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEA-S Medication Solutions5b423eba-0a35-41b0-9338-fa4c6f5c6c7f2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.18f44ba2-d431-4a73-ac78-83e734fde6942026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.d3628f24-8076-4980-a358-8445ef8260f42026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.19678edf-934a-45f3-b5da-94d10e9b32482026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
ndc (product): 43063-821
Metoprolol TartrateMETOPROLOL TARTRATENuCare Pharmaceuticals, Inc.47d18ba7-558d-1190-e063-6294a90a958f2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCf318d14a-9f96-4238-e053-2995a90abc152026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCf319e981-81ff-22da-e053-2a95a90a27382026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATENorthwind Health Company, LLCd9cbda2a-70d9-74d3-e053-2a95a90aacc12026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma Inc2ad0606c-7a90-44bd-a75d-d256de30fbcf2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma Inc85a638c3-d53c-453d-935c-fcfd31372a452025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEQPharma, Inc.c0e147a8-36a6-1e61-e053-2a95a90afd622025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.f4a4da81-c4d0-4a00-9f08-9029b5d9b5ea2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.00de1f16-f979-4dbf-aa60-246ffac8d4102025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077739
application number: ANDA077739

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866514metoprolol tartrate 50 MG Oral TabletPSN19678edf-934a-45f3-b5da-94d10e9b324830
866514metoprolol tartrate 50 MG Oral TabletSCD19678edf-934a-45f3-b5da-94d10e9b324830

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-821-304306308213030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-30) 2018-06-272027-08-31NoNoCurrent
43063-821-604306308216060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-60) 2018-05-172027-08-31NoNoCurrent
43063-821-904306308219090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-90) 2017-01-052027-08-31NoNoCurrent
43063-821-9343063082193180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-93) 2017-01-052027-08-31NoNoCurrent