Dobutamine Hydrochloride in Dextrose

Product NDC: 0338-1077
11-digit product format: 003381077
Labeler code: 0338
Product ID: 0338-1077_34c787c1-46f7-4264-951d-c88a34dca533
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dobutamine Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA020255
Marketing category: NDA
Marketing start: 1993-09-23
Substance: DOBUTAMINE HYDROCHLORIDE
Active strength: 400 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 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
N020255-001	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 50MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020255-003	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 100MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020255-004	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 200MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19
N020255-005	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	DOBUTAMINE HYDROCHLORIDE	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020255-001	AP
N020255-003	AP
N020255-004	AP
N020255-005	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	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…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020255-001	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	N020255-003	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	N020255-004	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	N020255-005	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020255-001	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	N020255-003	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	N020255-004	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	N020255-005	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020255-001	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	N020255-003	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	N020255-004	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	N020255-005	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	EQ 400MG BASE/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1993-10-19	`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	N020255-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020255-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020255-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020255-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020255-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020255-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020255-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020255-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020255-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020255-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020255-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020255-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020255-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020255-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020255-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020255-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020255-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020255-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020255-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020255-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020255-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020255-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020255-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020255-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020255-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020255-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020255-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020255-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020255-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020255-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020255-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020255-005	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020255-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020255-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020255-004	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020255-005	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020255-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020255-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020255-004	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020255-005	AP	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dobutamine Hydrochloride in Dextrose
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOBUTAMINE HYDROCHLORIDE	400 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309985	Internal RxNorm lookup
309986	Internal RxNorm lookup
309987	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
6b17b98b-e06d-42ed-925f-69aa2699dead	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c061d745-4e41-be68-87e9-bad2cb726830	Product name	2	20240208
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
020518de-5dfd-f3a9-9c93-8015dad30497	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-1077-02	Dobutamine Hydrochloride in Dextrose	18 in 1 CARTON	INJECTION	18		23
0338-1077-02	Dobutamine Hydrochloride in Dextrose	250 mL in 1 BAG	INJECTION	250		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-1077-02	ML - Milliliter	0338-1077	2b8a7cd3-264a-4d82-b83d-efa9347ecf72	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOBUTAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0WR771DJXV	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
DOBUTAMINE	ACTIVE MOIETY	3S12J47372	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
SODIUM BISULFITE	INACTIVE INGREDIENT	TZX5469Z6I	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-1077	DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [BAXTER HEALTHCARE CORPORATION]	22	Current NDC, Legacy NDC, 2 package rows	20250315_6b17b98b-e06d-42ed-925f-69aa2699dead.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c6ceb8d3-e46e-f0da-e053-2995a90a8c3c	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020255 application number: NDA020255
Dobutamine Hydrochloride in Dextrose	DOBUTAMINE HYDROCHLORIDE	Baxter Healthcare Corporation	6b17b98b-e06d-42ed-925f-69aa2699dead	2023-09-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020255 application number: NDA020255 ndc (product): 0338-1077

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309987	DOBUTamine 1000 MG in 250 ML Injection	PSN	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309985	DOBUTamine 250 MG in 250 ML Injection	PSN	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309986	DOBUTamine 500 MG in 250 ML Injection	PSN	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309985	250 ML dobutamine 1 MG/ML Injection	SCD	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309986	250 ML dobutamine 2 MG/ML Injection	SCD	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309987	250 ML dobutamine 4 MG/ML Injection	SCD	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309987	dobutamine (as dobutamine HCl) 1000 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309985	dobutamine (as dobutamine HCl) 250 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309986	dobutamine (as dobutamine HCl) 500 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309987	dobutamine 1000 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309985	dobutamine 250 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309986	dobutamine 500 MG per 250 ML Injection	SY	6b17b98b-e06d-42ed-925f-69aa2699dead	23
309987	DOBUTamine 1000 MG in 250 ML Injection	PSN	7f56a751-5769-4622-9008-e7fef8e54362	5
309987	250 ML dobutamine 4 MG/ML Injection	SCD	7f56a751-5769-4622-9008-e7fef8e54362	5
309987	dobutamine (as dobutamine HCl) 1000 MG per 250 ML Injection	SY	7f56a751-5769-4622-9008-e7fef8e54362	5
309987	dobutamine 1000 MG per 250 ML Injection	SY	7f56a751-5769-4622-9008-e7fef8e54362	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-1077-02	00338107702	18 BAG in 1 CARTON (0338-1077-02) / 250 mL in 1 BAG	18 bag	1993-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOBUTamine Hydrochloride in 5% Dextrose Injection in Plastic Container Viaflex Plus Container	Baxter Healthcare Corporation	2023-09-08	HUMAN PRESCRIPTION DRUG LABEL	23
DOBUTamine Hydrochloride in 5% Dextrose Injection in Plastic Container VIAFLEX PLUS Container	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	5