Home NDC 0409-2344 DOBUTAMINE
Product NDC 0409-2344
11-digit product format 004092344
Labeler code 0409
Product ID 0409-2344_5d6b1dfe-d679-4aea-97a6-3d074a202afe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOBUTAMINE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074086
Marketing category ANDA
Marketing start 2005-04-30
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 A074086-001 DOBUTAMINE HYDROCHLORIDE DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074086-001 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 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1993-11-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1993-11-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1993-11-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP 1993-11-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074086-001 DOBUTAMINE HYDROCHLORIDE EQ 12.5MG BASE/ML INJECTABLE / INJECTION AP RS 1993-11-29 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 0409-2344-68 DOBUTAMINE 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 19 0409-2344-88 DOBUTAMINE 10 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 10 19 0409-2344-01 DOBUTAMINE 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 11 0409-2344-01 DOBUTAMINE 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 11 0409-2344-02 DOBUTAMINE 10 in 1 TRAY INJECTION, SOLUTION, CONCENTRATE 10 11 0409-2344-62 DOBUTAMINE 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DOBUTAMINE HYDROCHLORIDE ACTIVE INGREDIENT 0WR771DJXV DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 DOBUTAMINE ACTIVE MOIETY 3S12J47372 DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2344 DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 18 Current NDC, Legacy NDC, 2 package rows 20241211_89becb0c-da60-4f43-0a98-29ff7a9eca58.zip 0409-2344 DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20241210_dc537761-d5f4-488d-24ab-b2bcd2b17b7a.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-2344-01 00409234401 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2005-08-03 0000-00-00 No No Current 0409-2344-02 00409234402 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-62) 2005-06-29 0000-00-00 No No Current 0409-2344-62 00409234462 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 0409-2344-68 00409234468 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 0409-2344-88 00409234488 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-88) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-68) 2005-04-30 0000-00-00 No No Current