Home NDC 51662-1337 DOBUTAMINE
Product NDC 51662-1337
11-digit product format 516621337
Labeler code 51662
Product ID 51662-1337_11c1b110-433c-7887-e063-6294a90a1e52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DOBUTAMINE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA074086
Marketing category ANDA
Marketing start 2018-11-26
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51662-1337-1 DOBUTAMINE 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 6 51662-1337-2 DOBUTAMINE 1 in 1 POUCH INJECTION, SOLUTION, CONCENTRATE 1 6 51662-1337-2 DOBUTAMINE 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 20 6 51662-1337-3 DOBUTAMINE 10 in 1 CASE INJECTION, SOLUTION, CONCENTRATE 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1337 DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 6 Current NDC, Legacy NDC, 4 package rows 20240220_7b9ea626-7072-2e77-e053-2a91aa0a9215.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 51662-1337-1 51662133701 20 mL in 1 VIAL, SINGLE-DOSE (51662-1337-1) 20 ml 2018-11-26 0000-00-00 No No Current 51662-1337-2 51662133702 1 in 1 POUCH Historical 51662-1337-3 51662133703 10 POUCH in 1 CASE (51662-1337-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1337-2) / 20 mL in 1 VIAL, SINGLE-DOSE 10 pouch 2022-06-12 0000-00-00 No No Current