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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27
N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINERDOPAMINE HYDROCHLORIDE640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N019615-001AP
N019615-002AP
N019615-003AP

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019615-001DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER80MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-002DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER160MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-003DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER320MG/100MLINJECTABLE / INJECTIONAPRLD, RS1987-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-004DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER640MG/100MLINJECTABLE / INJECTIONRLD, RS1987-03-27d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019615-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019615-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019615-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019615-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019615-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019615-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019615-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019615-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019615-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019615-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019615-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019615-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019615-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019615-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019615-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019615-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019615-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Dopamine Hydrochloride and Dextrose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE160 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7L3E358N9LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1743877Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ef116db-fb26-1e66-e063-6294a90a0610Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
6aba2aa6-bc33-4b0c-a81c-06f5fb4cc762Product name220180613
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
b2a69ae1-a082-5ec0-42b6-e3c38800f173Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84549-007-02Dopamine Hydrochloride and Dextrose250 mL in 1 BAGINJECTION, SOLUTION2502

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEProPharma Distribution3ef116db-fb26-1e66-e063-6294a90a06102025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019615
application number: NDA019615
ndc (product): 84549-007
Dopamine Hydrochloride and DextroseDOPAMINE HYDROCHLORIDEBaxter Healthcare Corporationcb97d4a0-89ed-407c-a763-209386b6f75c2020-11-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019615
application number: NDA019615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN3ef116db-fb26-1e66-e063-6294a90a06102
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD3ef116db-fb26-1e66-e063-6294a90a06102
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY3ef116db-fb26-1e66-e063-6294a90a06102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-007-0284549000702250 mL in 1 BAG (84549-007-02) 250 ml2025-09-17NoNoCurrent