FDA.reportPublic FDA data

Metoprolol Tartrate

Product NDC
0409-1778
11-digit product format
004091778
Labeler code
0409
Product ID
0409-1778_25fb7425-bc57-4216-8fc8-0bbec3d1125b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METOPROLOL TARTRATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078085
Marketing category
ANDA
Marketing start
2008-07-24
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

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 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
0409-1778-05Metoprolol Tartrate10 in 1 CARTONINJECTION, SOLUTION1029
0409-1778-15Metoprolol Tartrate5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION529

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1778-05ML - Milliliter0409-17789146ced6-1876-4045-ae46-aa9b0a156a2712012-07-24
0409-1778-15ML - Milliliter0409-1778e93891f7-06f2-4a5f-9f74-717fc243223312018-03-08
0409-1778-30ML - Milliliter0409-17784c74bce2-b36c-479e-9106-834296e8932b12018-03-08
0409-1778-35ML - Milliliter0409-17785b60583c-97a8-483a-8ecf-1843b9e816dd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METOPROLOL TARTRATEACTIVE INGREDIENTW5S57Y3A5LMETOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]15
METOPROLOLACTIVE MOIETYGEB06NHM23METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]15
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RMETOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]15
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
0409-1778METOPROLOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]28Current NDC, Legacy NDC, 2 package rows20241129_7c1f998a-233d-4feb-6ea2-457702abd0d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN7c1f998a-233d-4feb-6ea2-457702abd0d229
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD7c1f998a-233d-4feb-6ea2-457702abd0d229
866508metoprolol tartrate 5 MG per 5 ML InjectionSY7c1f998a-233d-4feb-6ea2-457702abd0d229
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
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN99b22be0-d2b4-2449-e053-2995a90a6c285
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD99b22be0-d2b4-2449-e053-2995a90a6c285
866508metoprolol tartrate 5 MG per 5 ML InjectionSY99b22be0-d2b4-2449-e053-2995a90a6c285
866508metoprolol tartrate 5 MG in 5 ML InjectionPSN3ef0affa-a2f7-92de-e063-6294a90ad4d01
8665085 ML metoprolol tartrate 1 MG/ML InjectionSCD3ef0affa-a2f7-92de-e063-6294a90ad4d01
866508metoprolol tartrate 5 MG per 5 ML InjectionSY3ef0affa-a2f7-92de-e063-6294a90ad4d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-1778-050040917780510 VIAL, SINGLE-DOSE in 1 CARTON (0409-1778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-1778-15) 2008-07-240000-00-00NoNoCurrent
0409-1778-15004091778155 mL in 1 VIAL, SINGLE-DOSE5 mlHistorical