Metoprolol Tartrate

Product NDC
55154-4745
11-digit product format
551544745
Labeler code
55154
Product ID
55154-4745_0b7cb76a-3b5f-4b65-89e7-a758a48c4b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA078085
Marketing category
ANDA
Marketing start
2008-04-29
Substance
METOPROLOL TARTRATE
Active strength
1 mg/mL
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 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
A078085-001METOPROLOL TARTRATEMETOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078085-001AP

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 06:07:402026-07A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-293f01610625f2…
2019-09-15 20:21 UTC2019-09A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078085-001METOPROLOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS2008-04-29e64feba35796…

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 06:07:402026-07A078085-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078085-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078085-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078085-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078085-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078085-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078085-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078085-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078085-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078085-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078085-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078085-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078085-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078085-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078085-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078085-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078085-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078085-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078085-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078085-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078085-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078085-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A078085-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078085-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078085-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078085-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A078085-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078085-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078085-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078085-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078085-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078085-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078085-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078085-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078085-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078085-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078085-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078085-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078085-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078085-001AP1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE1 mg/mL

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
a670d75a-ec69-4570-a3be-c57b896fc553Available 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
55154-4745-5Metoprolol Tartrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION510
55154-4745-5Metoprolol Tartrate5 in 1 BAGINJECTION, SOLUTION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-4745-5ML - Milliliter55154-4745887a259d-0532-4038-b57b-995f4711d5da12017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH]1
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4745METOPROLOL TARTRATE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250206_a670d75a-ec69-4570-a3be-c57b896fc553.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOPROLOL TARTRATECardinal Health 107, LLCa670d75a-ec69-4570-a3be-c57b896fc5532026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078085
application number: ANDA078085
ndc (product): 55154-4745
Metoprolol TartrateMETOPROLOL TARTRATEHospira, Inc.7c1f998a-233d-4feb-6ea2-457702abd0d22026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078085
application number: ANDA078085
Metoprolol TartrateMETOPROLOL TARTRATEHospira, Inc.f65e93ec-4db6-44fa-bff1-8ae89aa8243f2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078085
application number: ANDA078085
Metoprolol TartrateMETOPROLOL TARTRATEProPharma Distribution3ef0affa-a2f7-92de-e063-6294a90ad4d02025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078085
application number: ANDA078085
METOPROLOL TARTRATEMETOPROLOL TARTRATEHF Acquisition Co LLC, DBA HealthFirst99b22be0-d2b4-2449-e053-2995a90a6c282024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078085
application number: ANDA078085

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNa670d75a-ec69-4570-a3be-c57b896fc55310
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDa670d75a-ec69-4570-a3be-c57b896fc55310
866508metoprolol tartrate 5 MG per 5 ML InjectionSYa670d75a-ec69-4570-a3be-c57b896fc55310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-4745-5551544745055 VIAL, SINGLE-DOSE in 1 BAG (55154-4745-5) / 5 mL in 1 VIAL, SINGLE-DOSE2008-04-290000-00-00NoNoCurrent