FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
25021-303
11-digit product format
250210303
Labeler code
25021
Product ID
25021-303_b0c162ae-0af5-4443-9136-edf762c90e11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metoprolol Tartrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA204205
Marketing category
ANDA
Marketing start
2010-05-10
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Metoprolol Tartrate
Listing expiration
2026-12-31

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
25021-303-05Metoprolol Tartrate5 mL in 1 VIALINJECTION, SOLUTION511
25021-303-05Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-303-05ML - Milliliter25021-3030e961f29-1edc-4939-91c3-bf2dd8224d2112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metoprolol tartrateACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL (METOPROLOL TARTRATE) INJECTION [SAGENT PHARMACEUTICALS]8
metoprololACTIVE MOIETYGEB06NHM23METOPROLOL (METOPROLOL TARTRATE) INJECTION [SAGENT PHARMACEUTICALS]8
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMETOPROLOL (METOPROLOL TARTRATE) INJECTION [SAGENT PHARMACEUTICALS]8
waterINACTIVE INGREDIENT059QF0KO0RMETOPROLOL (METOPROLOL TARTRATE) INJECTION [SAGENT PHARMACEUTICALS]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-303METOPROLOL TARTRATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]11Current NDC, 2 package rows20230809_f3817543-544a-4afa-ac7c-c1b48c1307c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSNf3817543-544a-4afa-ac7c-c1b48c1307c211
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCDf3817543-544a-4afa-ac7c-c1b48c1307c211
866508metoprolol tartrate 5 MG per 5 ML InjectionSYf3817543-544a-4afa-ac7c-c1b48c1307c211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-303-052502103030510 VIAL in 1 CARTON (25021-303-05) / 5 mL in 1 VIAL10 vial2010-05-10NoNoCurrent