Dobutamine

Product NDC: 14335-171
11-digit product format: 143350171
Labeler code: 14335
Product ID: 14335-171_f153e636-62ab-3b86-e053-2995a90a36c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dobutamine
Dosage form: INJECTION, SOLUTION, CONCENTRATE
Route: INTRAVENOUS
Labeler: Hainan Poly Pharm. Co., Ltd.
Application: ANDA216131
Marketing category: ANDA
Marketing start: 2021-06-01
Marketing end: 0000-00-00
Substance: DOBUTAMINE HYDROCHLORIDE
Active strength: 13 mg/mL
Pharmacologic classes: Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	14335-171		I	Inactivated by FDA		2026-08-07
excluded package	package	14335-171	14335-171-01	I	Inactivated by FDA		2026-08-07

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
14335-171-01	2026-01-29	C162847	48780-1	49896155-a5a9-586f-e063-e6dba90add90	Dobutamine Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
14335-171-01	Dobutamine	1 in 1 CARTON	INJECTION, SOLUTION, CONCENTRATE	1		2
14335-171-01	Dobutamine	20 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION, CONCENTRATE	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
14335-171	DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HAINAN POLY PHARM. CO., LTD.]	2	Legacy NDC, 2 package rows	20230104_9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55.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

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	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812170	DOBUTamine 500 MG in 40 ML Injection	PSN	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812168	20 ML dobutamine 12.5 MG/ML Injection	SCD	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812170	40 ML dobutamine 12.5 MG/ML Injection	SCD	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812168	dobutamine (as dobutamine HCl) 250 MG per 20 ML Injection	SY	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812170	dobutamine (as dobutamine HCl) 500 MG per 40 ML Injection	SY	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812168	dobutamine 250 MG per 20 ML Injection	SY	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2
1812170	dobutamine 500 MG per 40 ML Injection	SY	9794e9d0-c8b7-4d18-8cd1-15cc4f2a9a55	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
14335-171-01	14335017101	1 VIAL, SINGLE-DOSE in 1 CARTON (14335-171-01) > 20 mL in 1 VIAL, SINGLE-DOSE	2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dobutamine Injection, USP	Hainan Poly Pharm. Co., Ltd.	2023-01-02	HUMAN PRESCRIPTION DRUG LABEL	2