Dobutamine

Product NDC: 70436-203
11-digit product format: 704360203
Labeler code: 70436
Product ID: 70436-203_49562559-8e19-fb8a-e063-6394a90a0966
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dobutamine
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Slate Run Pharmaceuticals
Application: ANDA216131
Marketing category: ANDA
Marketing start: 2023-04-03
Substance: DOBUTAMINE HYDROCHLORIDE
Active strength: 250 mg/20mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216131-001	DOBUTAMINE HYDROCHLORIDE	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP		2022-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216131-001	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.

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	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216131-001	DOBUTAMINE HYDROCHLORIDE	EQ 12.5MG BASE/ML	INJECTABLE / INJECTION	AP	2022-12-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216131-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216131-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216131-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216131-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216131-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216131-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216131-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216131-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216131-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216131-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216131-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216131-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216131-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216131-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216131-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216131-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216131-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216131-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216131-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216131-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216131-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216131-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A216131-001	AP	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216131-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOBUTAMINE HYDROCHLORIDE	250 mg/20mL

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
1812168	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
ee09a55f-9992-48bb-b8d6-1184bd548536	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
020518de-5dfd-f3a9-9c93-8015dad30497	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70436-203-80	Dobutamine	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION	20	4
70436-203-80	Dobutamine	1 in 1 CARTON	INJECTION	1	4
70436-203-82	Dobutamine	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION	20	4
70436-203-82	Dobutamine	10 in 1 CARTON	INJECTION	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70436-203-80	ML - Milliliter	70436-203	9721900d-0eb5-4d12-beb2-e4c8d38bede7	1	2023-07-06
70436-203-82	ML - Milliliter	70436-203	280471f7-9c5d-4384-9f65-76f107cb70c9	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70436-203	DOBUTAMINE INJECTION [SLATE RUN PHARMACEUTICALS]	3	Current NDC, 4 package rows	20230403_ee09a55f-9992-48bb-b8d6-1184bd548536.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dobutamine	DOBUTAMINE	Slate Run Pharmaceuticals	ee09a55f-9992-48bb-b8d6-1184bd548536	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216131 application number: ANDA216131 ndc (product): 70436-203

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0WR771DJXV	DOBUTAMINE HYDROCHLORIDE	49745-95-1	DOBUTAMINE HYDROCHLORIDE
3S12J47372	DOBUTAMINE	34368-04-2	dobutamine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1812168	DOBUTamine 250 MG in 20 ML Injection	PSN	ee09a55f-9992-48bb-b8d6-1184bd548536	4
1812168	20 ML dobutamine 12.5 MG/ML Injection	SCD	ee09a55f-9992-48bb-b8d6-1184bd548536	4
1812168	dobutamine (as dobutamine HCl) 250 MG per 20 ML Injection	SY	ee09a55f-9992-48bb-b8d6-1184bd548536	4
1812168	dobutamine 250 MG per 20 ML Injection	SY	ee09a55f-9992-48bb-b8d6-1184bd548536	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70436-203-80	70436020380	1 VIAL, SINGLE-DOSE in 1 CARTON (70436-203-80) / 20 mL in 1 VIAL, SINGLE-DOSE	2023-04-03	No	No	Current
70436-203-82	70436020382	10 VIAL, SINGLE-DOSE in 1 CARTON (70436-203-82) / 20 mL in 1 VIAL, SINGLE-DOSE	2023-04-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dobutamine injection	Slate Run Pharmaceuticals \| Hainan Poly Pharm. Co., Ltd.	2026-01-26	HUMAN PRESCRIPTION DRUG LABEL	4