FDA.reportPublic FDA data

Dopamine Hydrochloride and Dextrose

Product NDC
0338-1005
11-digit product format
003381005
Labeler code
0338
Product ID
0338-1005_edc9a091-4cb5-4ec7-b6f9-44d2d588bab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA019615
Marketing category
NDA
Marketing start
1987-03-27
Substance
DOPAMINE HYDROCHLORIDE
Active strength
80 mg/100mL
Pharmacologic classes
Catecholamine [EPC], Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dopamine Hydrochloride and Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE80 mg/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7L3E358N9L
Rxcui1292887, 1743869, 1743871, 1743877, 1743879

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
0338-1005-02Dopamine Hydrochloride and Dextrose18 in 1 CARTONINJECTION, SOLUTION1818
0338-1005-02Dopamine Hydrochloride and Dextrose250 mL in 1 BAGINJECTION, SOLUTION25018
0338-1005-03Dopamine Hydrochloride and Dextrose12 in 1 CARTONINJECTION, SOLUTION1218
0338-1005-03Dopamine Hydrochloride and Dextrose500 mL in 1 BAGINJECTION, SOLUTION50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-1005-02ML - Milliliter0338-100567a82e41-7be8-4583-bc3f-c67eeed2502d12012-07-24
0338-1005-03ML - Milliliter0338-100586afea82-5949-413c-94c8-f7acde8f14b112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOPAMINE HYDROCHLORIDEACTIVE INGREDIENT7L3E358N9LDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
DOPAMINEACTIVE MOIETYVTD58H1Z2XDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
SODIUM BISULFITEINACTIVE INGREDIENTTZX5469Z6IDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5
WATERINACTIVE INGREDIENT059QF0KO0RDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-1005DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]17Current NDC, Legacy NDC, 4 package rows20250410_cb97d4a0-89ed-407c-a763-209386b6f75c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSNcb97d4a0-89ed-407c-a763-209386b6f75c18
1743879DOPamine HCl 1600 MCG/ML in 500 ML InjectionPSNcb97d4a0-89ed-407c-a763-209386b6f75c18
1292887DOPamine HCl 3200 MCG/ML in 250 ML InjectionPSNcb97d4a0-89ed-407c-a763-209386b6f75c18
1743869DOPamine HCl 800 MCG/ML in 250 ML InjectionPSNcb97d4a0-89ed-407c-a763-209386b6f75c18
1743871DOPamine HCl 800 MCG/ML in 500 ML InjectionPSNcb97d4a0-89ed-407c-a763-209386b6f75c18
1743869250 ML dopamine hydrochloride 0.8 MG/ML InjectionSCDcb97d4a0-89ed-407c-a763-209386b6f75c18
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCDcb97d4a0-89ed-407c-a763-209386b6f75c18
1292887250 ML dopamine hydrochloride 3.2 MG/ML InjectionSCDcb97d4a0-89ed-407c-a763-209386b6f75c18
1743871500 ML dopamine hydrochloride 0.8 MG/ML InjectionSCDcb97d4a0-89ed-407c-a763-209386b6f75c18
1743879500 ML dopamine hydrochloride 1.6 MG/ML InjectionSCDcb97d4a0-89ed-407c-a763-209386b6f75c18
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSYcb97d4a0-89ed-407c-a763-209386b6f75c18
1743879dopamine HCl 1600 MCG/ML per 500 ML InjectionSYcb97d4a0-89ed-407c-a763-209386b6f75c18
1292887dopamine HCl 3200 MCG/ML per 250 ML InjectionSYcb97d4a0-89ed-407c-a763-209386b6f75c18
1743869dopamine HCl 800 MCG/ML per 250 ML InjectionSYcb97d4a0-89ed-407c-a763-209386b6f75c18
1743871dopamine HCl 800 MCG/ML per 500 ML InjectionSYcb97d4a0-89ed-407c-a763-209386b6f75c18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0338-1005-020033810050218 BAG in 1 CARTON (0338-1005-02) / 250 mL in 1 BAG18 bag1987-03-270000-00-00NoNoCurrent
0338-1005-030033810050312 BAG in 1 CARTON (0338-1005-03) / 500 mL in 1 BAG12 bag1987-03-270000-00-00NoNoCurrent