Home NDC 50090-4562 Dobutamine Hydrochloride in Dextrose
Product NDC 50090-4562
11-digit product format 500904562
Labeler code 50090
Product ID 50090-4562_d85c0585-91ca-47d3-9da7-87f9d53183d6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dobutamine Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler A-S Medication Solutions
Application NDA020255
Marketing category NDA
Marketing start 1993-09-23
Marketing end 0000-00-00
Substance DOBUTAMINE HYDROCHLORIDE
Active strength 400 mg/100mL
Pharmacologic classes Adrenergic beta-Agonists [MoA],beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-4562-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-4562-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-4562-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-4562-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-4562-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-4562-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-4562-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-4562-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-4562-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-4562-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-4562-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-4562-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-4562-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-4562-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-4562-0 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOBUTAMINE HYDROCHLORIDE EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 172 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 2026-09-14 22:38:34 2026-08 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020255-001 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 50MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020255-003 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 100MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020255-004 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 200MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020255-005 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER EQ 400MG BASE/100ML INJECTABLE / INJECTION AP RLD, RS 1993-10-19 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 50090-4562-0 Dobutamine Hydrochloride in Dextrose 250 mL in 1 BAG INJECTION 250 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4562 DOBUTAMINE HYDROCHLORIDE IN DEXTROSE (DOBUTAMINE HYDROCHLORIDE) INJECTION [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 1 package rows 20210417_7f56a751-5769-4622-9008-e7fef8e54362.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 · 2 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 50090-4562-0 50090456200 250 mL in 1 BAG (50090-4562-0) 250 ml 2019-09-26 0000-00-00 No No Current