Home NDC 0143-9141 Dobutamine
Product NDC 0143-9141
11-digit product format 001439141
Labeler code 0143
Product ID 0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dobutamine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074277
Marketing category ANDA
Marketing start 2023-05-03
Substance DOBUTAMINE HYDROCHLORIDE
Active strength 12.5 mg/mL
Pharmacologic classes Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074277-001 DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074277-001 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.
Product history page 1 of 2 · 41 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 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074277-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1994-10-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dobutamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOBUTAMINE HYDROCHLORIDE 12.5 mg/mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0143-9141-10 Dobutamine 20 mL in 1 VIAL INJECTION, SOLUTION 20 6 0143-9141-10 Dobutamine 10 in 1 CARTON INJECTION, SOLUTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9141 DOBUTAMINE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 6 Current NDC, 2 package rows 20240711_74ba9408-17d3-48ac-be0b-a4fee9e7a1a5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0143-9141-10 00143914110 10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIAL 10 vial 2023-05-03 No No Current