Home NDC 51662-1566-1 DOBUTAMINE HYDROCHLORIDE
Product NDC 51662-1566
Requested package NDC 51662-1566-1
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 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 50MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 100MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 200MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 400MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DOBUTAMINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOBUTAMINE HYDROCHLORIDE 100 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0WR771DJXV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309985 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1566-1 DOBUTAMINE HYDROCHLORIDE 250 mL in 1 BAG INJECTION 250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1566 DOBUTAMINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 1 package rows 20240201_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51662-1566-1 51662156601 250 mL in 1 BAG (51662-1566-1) 250 ml 2021-07-10 0000-00-00 No No Current