DOBUTAMINE IN DEXTROSE

Product NDC: 51662-1705
Requested package NDC: 51662-1705-1
11-digit product format: 516621705
Labeler code: 51662
Product ID: 51662-1705_559367ef-5c21-99ea-e063-6294a90a4ff2
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: 2026-03-16
Substance: DOBUTAMINE HYDROCHLORIDE
Active strength: 200 mg/100mL
Pharmacologic classes: Adrenergic beta-Agonists [MoA]; beta-Adrenergic Agonist [EPC]
Listing certified through: 2027-12-31
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-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	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020201-002	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020201-003	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 50MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020201-006	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020201-001	AP
N020201-002	AP
N020201-003	AP
N020201-006	AP

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-001	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 200MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-002	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-003	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-006	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-001	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 200MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-002	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-003	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-006	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020201-001	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 200MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-002	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-003	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 50MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-006	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1994-07-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020201-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020201-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020201-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020201-006	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020201-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020201-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020201-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020201-006	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020201-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020201-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020201-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020201-006	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020201-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020201-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020201-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020201-006	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020201-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020201-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020201-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020201-006	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020201-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020201-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020201-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020201-006	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020201-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020201-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020201-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020201-006	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020201-006	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020201-006	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020201-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020201-006	AP	1	`d06236e962d9…`

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	200 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
309986	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
559367ef-5c20-99ea-e063-6294a90a4ff2	Available on FDA.report

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 · 5 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 ndc (package): 51662-1705-1 ndc (product): 51662-1705 ndc11 (package): 51662170501
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
DOBUTAMINE	DOBUTAMINE	HF Acquisition Co LLC, DBA HealthFirst	85fb5ba6-3597-e09f-e053-2a91aa0aded5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020201 application number: NDA020201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0WR771DJXV	DOBUTAMINE HYDROCHLORIDE	49745-95-1	DOBUTAMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
51662-1705-1	51662170501	250 mL in 1 BAG (51662-1705-1)	250 ml	2026-03-16	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOBUTAMINE IN DEXTROSE - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-07-01	HUMAN PRESCRIPTION DRUG LABEL	1