Home NDC 51662-1664 DOBUTAMINE IN DEXTROSE
Product NDC 51662-1664
11-digit product format 516621664
Labeler code 51662
Product ID 51662-1664_47bf8f3f-ee08-c235-e063-6394a90a96fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOBUTAMINE IN DEXTROSE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler HF Acquisition Co. LLC, DBA HealthFirst
Application NDA020201
Marketing category NDA
Marketing start 2005-08-12
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 2027-12-31
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 N020201-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 200MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020201-002 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 100MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020201-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 50MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1993-10-19 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 400MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1994-07-07
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 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML SOLUTION / INTRAVENOUS AP RLD, RS 1994-07-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020201-001 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 N020201-002 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 N020201-003 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 N020201-006 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1994-07-07 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 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 IN DEXTROSE
Listing expiration 2027-12-31 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 51662-1664-1 DOBUTAMINE IN DEXTROSE 250 mL in 1 BAG INJECTION, SOLUTION 250 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1664 DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION [HF ACQUISITION CO. LLC, DBA HEALTHFIRST] 1 Current NDC, 1 package rows 20250503_3418aa46-2d9a-39f3-e063-6294a90a2961.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DOBUTAMINE IN DEXTROSE DOBUTAMINE IN DEXTROSE HF Acquisition Co LLC, DBA HealthFirst 559367ef-5c20-99ea-e063-6294a90a4ff2 2026-07-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 020201 application number: NDA020201 Dobutamine in Dextrose DOBUTAMINE IN DEXTROSE Hospira, Inc. 9943a961-3b50-4847-8a84-d8414ce38daa 2026-06-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 020201 application number: NDA020201 DOBUTAMINE IN DEXTROSE DOBUTAMINE IN DEXTROSE HF Acquisition Co LLC, DBA HealthFirst 52f70858-7cf9-2ff1-e063-6294a90ac46c 2026-05-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 020201 application number: NDA020201 DOBUTAMINE IN DEXTROSE DOBUTAMINE IN DEXTROSE HF Acquisition Co. LLC, DBA HealthFirst 3418aa46-2d9a-39f3-e063-6294a90a2961 2026-01-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 020201 application number: NDA020201 ndc (product): 51662-1664
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51662-1664-1 51662166401 250 mL in 1 BAG (51662-1664-1) 250 ml 2005-08-12 No No Current