Dobutamine

Product NDC
0143-9141
11-digit product format
001439141
Labeler code
0143
Product ID
0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dobutamine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074277
Marketing category
ANDA
Marketing start
2023-05-03
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
12.5 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOBUTAMINE HYDROCHLORIDE12.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0WR771DJXV
Rxcui1812168

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c061d745-4e41-be68-87e9-bad2cb726830Product name220240208
020518de-5dfd-f3a9-9c93-8015dad30497Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9141-10Dobutamine20 mL in 1 VIALINJECTION, SOLUTION206
0143-9141-10Dobutamine10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9141-10ML - Milliliter0143-91414e90dd8a-637d-4a9b-af94-da87c4543c6f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9141DOBUTAMINE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, 2 package rows20240711_74ba9408-17d3-48ac-be0b-a4fee9e7a1a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812168DOBUTamine 250 MG in 20 ML InjectionPSN74ba9408-17d3-48ac-be0b-a4fee9e7a1a56
181216820 ML dobutamine 12.5 MG/ML InjectionSCD74ba9408-17d3-48ac-be0b-a4fee9e7a1a56
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSY74ba9408-17d3-48ac-be0b-a4fee9e7a1a56
1812168dobutamine 250 MG per 20 ML InjectionSY74ba9408-17d3-48ac-be0b-a4fee9e7a1a56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9141-100014391411010 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL10 vial2023-05-03NoNoHistorical