FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
72611-740
11-digit product format
726110740
Labeler code
72611
Product ID
72611-740_ede4ae40-88e0-0536-3e01-2f2ac0b5ae3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
metoprolol tartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Almaject, Inc.
Application
ANDA204205
Marketing category
ANDA
Marketing start
2020-03-31
Marketing end
2026-11-01
Substance
METOPROLOL TARTRATE
Active strength
1 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METOPROLOL TARTRATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW5S57Y3A5L
Rxcui866508

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
72611-740-01Metoprolol Tartrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION55
72611-740-10Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72611-740-01ML - Milliliter72611-74013d05756-80cf-4ec7-be64-367f262e875b12020-07-13
72611-740-10ML - Milliliter72611-7400742a361-ee21-4f0b-8116-896d08ad271312020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72611-740METOPROLOL TARTRATE INJECTION, SOLUTION [ALMAJECT, INC.]5Current NDC, Legacy NDC, 2 package rows20241019_f0370951-ab26-d4d1-b857-57518f3c4175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNf0370951-ab26-d4d1-b857-57518f3c41755
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDf0370951-ab26-d4d1-b857-57518f3c41755
866508metoprolol tartrate 5 MG per 5 ML InjectionSYf0370951-ab26-d4d1-b857-57518f3c41755
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNe93d7939-31ad-4fc5-a5f3-6d565cc6d0c14
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDe93d7939-31ad-4fc5-a5f3-6d565cc6d0c14
866508metoprolol tartrate 5 MG per 5 ML InjectionSYe93d7939-31ad-4fc5-a5f3-6d565cc6d0c14
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNb632f750-14a0-d27f-e053-2a95a90a1df32
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDb632f750-14a0-d27f-e053-2a95a90a1df32
866508metoprolol tartrate 5 MG per 5 ML InjectionSYb632f750-14a0-d27f-e053-2a95a90a1df32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72611-740-01726110740015 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical
72611-740-107261107401010 VIAL, SINGLE-DOSE in 1 CARTON (72611-740-10) / 5 mL in 1 VIAL, SINGLE-DOSE (72611-740-01) 2020-03-312026-11-01NoNoCurrent