Application 018398

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	40MG/ML	No	No
002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	INJECTABLE;INJECTION	80MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018398-001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION		Approved before 1982
N018398-002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION			1982-03-22

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018398-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018398-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION		1982-03-22	`3a93d1ddd44b…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOPamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Hospira, Inc.	1f306ad2-3606-4525-5a8a-ce78f426c1a2	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: DOPamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
Dopamine	DOPAMINE HYDROCHLORIDE	BioActive Nutritional, Inc.	5346622d-9719-493a-90f4-21f540d6cb2a	2026-03-30	Warnings	Name fallback generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride and Dextrose	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	3ef116db-fb26-1e66-e063-6294a90a0610	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DOPAMINE HYDROCHLORIDE
DOPamine Hydrochloride	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	45b0729e-529b-02f6-e063-6294a90a31d3	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: DOPamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Henry Schein, Inc.	fc1eb709-ce72-413e-9043-8e463ef0fd36	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Dopamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Henry Schein, Inc.	460906f7-b532-4ddb-a799-ad7b50488143	2025-08-05	Warnings, Adverse reactions	Name fallback brand name: Dopamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	38431050-007e-41b2-e063-6394a90a1d64	2025-07-18	Warnings, Adverse reactions	Name fallback brand name: Dopamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE PHENOLIC	DOPAMINE HYDROCHLORIDE	Energique, Inc.	d10ca5bc-2612-4589-a49c-1b9935fa0bf3	2024-10-24	Warnings	Name fallback generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	0e499952-46c7-4172-8c70-186312e240a3	2024-04-15	Warnings, Adverse reactions	Name fallback brand name: Dopamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c901b461-4f98-da0a-e053-2a95a90a106e	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: DOPAMINE HYDROCHLORIDE generic name: DOPAMINE HYDROCHLORIDE
Dopamine	DOPAMINE HYDROCHLORIDE	Deseret Biologicals, Inc.	b984b509-cdeb-4fc9-8133-be3b7ba82c8c	2024-02-20	Warnings	Name fallback generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c6c8539b-0da9-2d97-e053-2a95a90a3aa8	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: DOPAMINE HYDROCHLORIDE generic name: DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	7896052c-2a72-ca89-e053-2a91aa0ae86e	2024-01-29	Warnings, Adverse reactions	Name fallback brand name: DOPAMINE HYDROCHLORIDE generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	093312af-6eef-1f4b-e063-6294a90a155d	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: Dopamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
DOPamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b61fffd0-7bc8-09e2-e053-2995a90ae0e4	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: DOPamine Hydrochloride generic name: DOPAMINE HYDROCHLORIDE
Dopamine Hydrochloride and Dextrose	DOPAMINE HYDROCHLORIDE	Baxter Healthcare Corporation	cb97d4a0-89ed-407c-a763-209386b6f75c	2020-11-11	Warnings, Adverse reactions	Name fallback generic name: DOPAMINE HYDROCHLORIDE
Dopamine	DOPAMINE HYDROCHLORIDE	BioActive Nutritional	2e456b07-8b7b-463a-8cf5-1d7a51985b06	2016-08-16	Warnings	Name fallback generic name: DOPAMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.