DOBUTAMINE HYDROCHLORIDE

Product NDC
51662-1566
11-digit product format
516621566
Labeler code
51662
Product ID
51662-1566_1035c14e-d1ea-8603-e063-6394a90a430b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOBUTAMINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA020255
Marketing category
NDA
Marketing start
2021-07-10
Substance
DOBUTAMINE HYDROCHLORIDE
Active strength
100 mg/100mL
Pharmacologic classes
Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19
N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOBUTAMINE HYDROCHLORIDEEQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N020255-001AP
N020255-003AP
N020255-004AP
N020255-005AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020255-001DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 50MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-003DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 100MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-004DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 200MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-005DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINEREQ 400MG BASE/100MLINJECTABLE / INJECTIONAPRLD, RS1993-10-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020255-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-003AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020255-005AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-003AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020255-005AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020255-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-003AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020255-005AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-003AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-004AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020255-005AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-003AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-004AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020255-005AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-003AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-004AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020255-005AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-003AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-004AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020255-005AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-003AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-004AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020255-005AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-003AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-004AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020255-005AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020255-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-003AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-004AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020255-005AP1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOBUTAMINE HYDROCHLORIDE100 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0WR771DJXVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309985Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6ceb8d3-e46e-f0da-e053-2995a90a8c3cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c061d745-4e41-be68-87e9-bad2cb726830Product name220240208
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
020518de-5dfd-f3a9-9c93-8015dad30497Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1566-1DOBUTAMINE HYDROCHLORIDE250 mL in 1 BAGINJECTION2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1566DOBUTAMINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20240201_c6ceb8d3-e46e-f0da-e053-2995a90a8c3c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOBUTAMINE HYDROCHLORIDEDOBUTAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc6ceb8d3-e46e-f0da-e053-2995a90a8c3c2024-01-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 020255
application number: NDA020255
ndc (product): 51662-1566
Dobutamine Hydrochloride in DextroseDOBUTAMINE HYDROCHLORIDEBaxter Healthcare Corporation6b17b98b-e06d-42ed-925f-69aa2699dead2023-09-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020255
application number: NDA020255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309985DOBUTamine 250 MG in 250 ML InjectionPSNc6ceb8d3-e46e-f0da-e053-2995a90a8c3c3
309985250 ML dobutamine 1 MG/ML InjectionSCDc6ceb8d3-e46e-f0da-e053-2995a90a8c3c3
309985dobutamine (as dobutamine HCl) 250 MG per 250 ML InjectionSYc6ceb8d3-e46e-f0da-e053-2995a90a8c3c3
309985dobutamine 250 MG per 250 ML InjectionSYc6ceb8d3-e46e-f0da-e053-2995a90a8c3c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1566-151662156601250 mL in 1 BAG (51662-1566-1) 250 ml2021-07-100000-00-00NoNoCurrent