Metoprolol Tartrate

Product NDC
72572-420
11-digit product format
725720420
Labeler code
72572
Product ID
72572-420_08b65561-0817-44e6-a23b-b68ab6ee2666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoroprolol Tartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA077761
Marketing category
ANDA
Marketing start
2019-12-10
Substance
METOPROLOL TARTRATE
Active strength
5 mg/5mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077761-001METOPROLOL TARTRATEMETOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077761-001AP

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-303f01610625f2…
2019-09-15 20:21 UTC2019-09A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077761-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAP2007-05-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077761-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077761-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077761-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077761-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077761-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077761-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077761-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077761-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077761-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077761-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077761-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077761-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077761-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077761-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077761-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077761-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077761-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077761-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077761-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077761-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077761-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077761-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A077761-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077761-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077761-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077761-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A077761-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077761-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077761-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077761-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077761-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077761-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077761-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077761-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077761-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077761-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077761-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077761-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077761-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077761-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE5 mg/5mL

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
866508Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8dae76a2-32e7-40a2-bb70-9c6380b9b330Available 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
72572-420-01Metoprolol Tartrate5 mL in 1 VIALINJECTION, SOLUTION54
72572-420-10Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-420-01ML - Milliliter72572-42081709d02-b81b-4285-83d1-7b8adf00a0c312019-12-10
72572-420-10ML - Milliliter72572-4204e3554e1-858f-439c-9ea5-e6aa511c77f712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-420METOPROLOL TARTRATE (METOROPROLOL TARTRATE) INJECTION, SOLUTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20240704_8dae76a2-32e7-40a2-bb70-9c6380b9b330.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOROPROLOL TARTRATECivica, Inc.8dae76a2-32e7-40a2-bb70-9c6380b9b3302026-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077761
application number: ANDA077761
ndc (product): 72572-420
Metoprolol TartrateMETOROPROLOL TARTRATEHikma Pharmaceuticals USA Inc.c7ec36bb-bc6f-42de-9974-a50ac13e94102025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077761
application number: ANDA077761
Metoprolol TartrateMETOPROLOL TARTRATEMedical Purchasing Solutions, LLCb624095a-d1c1-1ce0-e053-2995a90a06982023-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077761
application number: ANDA077761
Metoprolol TartrateMETOROPROLOL TARTRATEMedical Purchasing Solutions, LLCbfc8834e-1df8-170b-e053-2995a90a28f12023-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077761
application number: ANDA077761

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN8dae76a2-32e7-40a2-bb70-9c6380b9b3304
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD8dae76a2-32e7-40a2-bb70-9c6380b9b3304
866508metoprolol tartrate 5 MG per 5 ML InjectionSY8dae76a2-32e7-40a2-bb70-9c6380b9b3304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-420-01725720420015 mL in 1 VIAL5 mlHistorical
72572-420-107257204201010 VIAL in 1 CARTON (72572-420-10) / 5 mL in 1 VIAL (72572-420-01) 10 vial2019-12-100000-00-00NoNoCurrent