Dobutamine

Product NDC
14335-172
11-digit product format
143350172
Labeler code
14335
Product ID
14335-172_f153e636-62ab-3b86-e053-2995a90a36c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dobutamine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA216131
Marketing category
ANDA
Marketing start
2021-06-01
Marketing end
0000-00-00
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
13 mg/mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14335-172-012026-01-29C16284748780-149896155-a5a9-586f-e063-e6dba90add90Dobutamine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14335-172-01Dobutamine40 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE402
14335-172-01Dobutamine1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-172DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HAINAN POLY PHARM. CO., LTD.]2Legacy NDC, 2 package rows20230104_9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812168DOBUTamine 250 MG in 20 ML InjectionPSN9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
1812170DOBUTamine 500 MG in 40 ML InjectionPSN9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
181216820 ML dobutamine 12.5 MG/ML InjectionSCD9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
181217040 ML dobutamine 12.5 MG/ML InjectionSCD9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
1812168dobutamine (as dobutamine HCl) 250 MG per 20 ML InjectionSY9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
1812170dobutamine (as dobutamine HCl) 500 MG per 40 ML InjectionSY9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
1812168dobutamine 250 MG per 20 ML InjectionSY9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552
1812170dobutamine 500 MG per 40 ML InjectionSY9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14335-172-01143350172011 VIAL, SINGLE-DOSE in 1 CARTON (14335-172-01) > 40 mL in 1 VIAL, SINGLE-DOSE2021-06-010000-00-00NoNoCurrent