Dopamine Hydrochloride

Product NDC: 0404-9982
11-digit product format: 004049982
Labeler code: 0404
Product ID: 0404-9982_680f3bae-9c24-46bb-bf97-09b638414fb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dopamine Hydrochloride
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: NDA018132
Marketing category: NDA
Marketing start: 2022-02-18
Substance: DOPAMINE HYDROCHLORIDE
Active strength: 40 mg/mL
Pharmacologic classes: Catecholamine [EPC], Catecholamines [CS]
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 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
N018132-001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N018132-002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04
N018132-003	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04
N018132-004	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018132-001	AP
N018132-002	AP
N018132-003	AP
N018132-004	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	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018132-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-002	DOPAMINE HYDROCHLORIDE	80MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-003	DOPAMINE HYDROCHLORIDE	160MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-02-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-004	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1982-07-09	`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	N018132-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018132-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018132-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018132-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018132-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018132-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018132-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018132-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018132-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018132-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018132-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018132-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018132-004	AP	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dopamine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOPAMINE HYDROCHLORIDE	40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7L3E358N9L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1743941	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
460906f7-b532-4ddb-a799-ad7b50488143	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762	Product name	2	20180613
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
b2a69ae1-a082-5ec0-42b6-e3c38800f173	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9982-05	Dopamine Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	5		6
0404-9982-05	Dopamine Hydrochloride	1 in 1 BAG	INJECTION, SOLUTION, CONCENTRATE	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9982	DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HENRY SCHEIN, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250221_460906f7-b532-4ddb-a799-ad7b50488143.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 · 7 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	Exact identifier application applno (NDA): 018132 application number: NDA018132
DOPamine Hydrochloride	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	45b0729e-529b-02f6-e063-6294a90a31d3	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Henry Schein, Inc.	fc1eb709-ce72-413e-9043-8e463ef0fd36	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Henry Schein, Inc.	460906f7-b532-4ddb-a799-ad7b50488143	2025-08-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132 ndc (product): 0404-9982
DOPAMINE HCI	DOPAMINE HCI	HF Acquisition Co. LLC, DBA Health First	74205252-3949-57fa-e053-2991aa0aee4d	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132
DOPAMINE HCI	DOPAMINE HCI	HF Acquisition Co LLC, DBA HealthFirst	763d2b07-9cea-782e-e053-2a91aa0adc01	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132
DOPamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	b61fffd0-7bc8-09e2-e053-2995a90ae0e4	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018132 application number: NDA018132

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7L3E358N9L	DOPAMINE HYDROCHLORIDE	62-31-7	DOPAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1743941	DOPamine HCl 40 MG/ML in 5 ML Injection	PSN	460906f7-b532-4ddb-a799-ad7b50488143	6
1743941	5 ML dopamine hydrochloride 40 MG/ML Injection	SCD	460906f7-b532-4ddb-a799-ad7b50488143	6
1743941	dopamine HCl 40 MG/ML per 5 ML Injection	SY	460906f7-b532-4ddb-a799-ad7b50488143	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9982-05	00404998205	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9982-05) / 5 mL in 1 VIAL, SINGLE-DOSE	2022-02-18	0000-00-00	No	No	Current