Dopamine Hydrochloride

Product NDC: 84549-252
11-digit product format: 845490252
Labeler code: 84549
Product ID: 84549-252_3a38fe9d-a5ef-a916-e063-6294a90adc8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dopamine Hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: ProPharma Distribution
Application: ANDA207707
Marketing category: ANDA
Marketing start: 2018-04-11
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207707-001	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP		2018-04-11
A207707-002	DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP		2018-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207707-001	AP
A207707-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207707-001	DOPAMINE HYDROCHLORIDE	40MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207707-002	DOPAMINE HYDROCHLORIDE	80MG/ML	INJECTABLE / INJECTION	AP	2018-04-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207707-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207707-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207707-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207707-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207707-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207707-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207707-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207707-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207707-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207707-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207707-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207707-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207707-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207707-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207707-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207707-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207707-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207707-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207707-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207707-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207707-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207707-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207707-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207707-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207707-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207707-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207707-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207707-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207707-002	AP	1	`782e0a99824c…`

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
38431050-007e-41b2-e063-6394a90a1d64	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762	Product name	2	20180613
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
84549-252-25	Dopamine Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION	5		2

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
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	ProPharma Distribution	38431050-007e-41b2-e063-6394a90a1d64	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707 ndc (product): 84549-252
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	0e499952-46c7-4172-8c70-186312e240a3	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c901b461-4f98-da0a-e053-2a95a90a106e	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707
DOPAMINE HYDROCHLORIDE	DOPAMINE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c6c8539b-0da9-2d97-e053-2a95a90a3aa8	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707
Dopamine Hydrochloride	DOPAMINE HYDROCHLORIDE	Medical Purchasing Solutions, LLC	093312af-6eef-1f4b-e063-6294a90a155d	2023-11-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207707 application number: ANDA207707

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	38431050-007e-41b2-e063-6394a90a1d64	2
1743941	5 ML dopamine hydrochloride 40 MG/ML Injection	SCD	38431050-007e-41b2-e063-6394a90a1d64	2
1743941	dopamine HCl 40 MG/ML per 5 ML Injection	SY	38431050-007e-41b2-e063-6394a90a1d64	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84549-252-25	84549025225	5 mL in 1 VIAL, SINGLE-DOSE (84549-252-25)	5 ml	2025-08-27	No	No	Current