FDA.reportPublic FDA data

Dobutamine

Product NDC
70436-203
11-digit product format
704360203
Labeler code
70436
Product ID
70436-203_49562559-8e19-fb8a-e063-6394a90a0966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dobutamine
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals
Application
ANDA216131
Marketing category
ANDA
Marketing start
2023-04-03
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
250 mg/20mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOBUTAMINE HYDROCHLORIDE250 mg/20mL

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
70436-203-80Dobutamine20 mL in 1 VIAL, SINGLE-DOSEINJECTION204
70436-203-80Dobutamine1 in 1 CARTONINJECTION14
70436-203-82Dobutamine20 mL in 1 VIAL, SINGLE-DOSEINJECTION204
70436-203-82Dobutamine10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-203-80ML - Milliliter70436-2039721900d-0eb5-4d12-beb2-e4c8d38bede712023-07-06
70436-203-82ML - Milliliter70436-203280471f7-9c5d-4384-9f65-76f107cb70c912023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-203DOBUTAMINE INJECTION [SLATE RUN PHARMACEUTICALS]3Current NDC, 4 package rows20230403_ee09a55f-9992-48bb-b8d6-1184bd548536.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812168DOBUTamine 250 MG in 20 ML InjectionPSNee09a55f-9992-48bb-b8d6-1184bd5485364
181216820 ML dobutamine 12.5 MG/ML InjectionSCDee09a55f-9992-48bb-b8d6-1184bd5485364
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSYee09a55f-9992-48bb-b8d6-1184bd5485364
1812168dobutamine 250 MG per 20 ML InjectionSYee09a55f-9992-48bb-b8d6-1184bd5485364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-203-80704360203801 VIAL, SINGLE-DOSE in 1 CARTON (70436-203-80) / 20 mL in 1 VIAL, SINGLE-DOSE2023-04-03NoNoCurrent
70436-203-827043602038210 VIAL, SINGLE-DOSE in 1 CARTON (70436-203-82) / 20 mL in 1 VIAL, SINGLE-DOSE2023-04-03NoNoCurrent