Home NDC 84549-007 Dopamine Hydrochloride and Dextrose
Product NDC 84549-007
11-digit product format 845490007
Labeler code 84549
Product ID 84549-007_463de4ca-e6b5-8c9a-e063-6394a90a70cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dopamine Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application NDA019615
Marketing category NDA
Marketing start 1987-03-27
Substance DOPAMINE HYDROCHLORIDE
Active strength 160 mg/100mL
Pharmacologic classes Catecholamine [EPC], Catecholamines [CS]
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 44 .
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 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER DOPAMINE HYDROCHLORIDE 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 176 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 2026-10-15 13:18:30 2026-09 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019615-001 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 80MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019615-002 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 160MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019615-003 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 320MG/100ML INJECTABLE / INJECTION AP RLD, RS 1987-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019615-004 DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER 640MG/100ML INJECTABLE / INJECTION RLD, RS 1987-03-27 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dopamine Hydrochloride and Dextrose
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOPAMINE HYDROCHLORIDE 160 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7L3E358N9L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1743877 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 84549-007-02 Dopamine Hydrochloride and Dextrose 250 mL in 1 BAG INJECTION, SOLUTION 250 2
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 Sample Exclude flag Status 84549-007-02 84549000702 250 mL in 1 BAG (84549-007-02) 250 ml 2025-09-17 No No Current