FDA.reportPublic FDA data

Dopamine Hydrochloride in Dextrose

Product NDC
0409-7809
11-digit product format
004097809
Labeler code
0409
Product ID
0409-7809_188ce800-ff3a-4b22-9a95-2273c3bc99ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dopamine Hydrochloride in Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA018826
Marketing category
NDA
Marketing start
2005-04-30
Substance
DOPAMINE HYDROCHLORIDE
Active strength
1.6 mg/mL
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 in Dextrose
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOPAMINE HYDROCHLORIDE1.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7L3E358N9L
Rxcui1292887, 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
0409-7809-11Dopamine Hydrochloride in Dextrose250 mL in 1 BAGINJECTION, SOLUTION25027
0409-7809-22Dopamine Hydrochloride in Dextrose12 in 1 CARTONINJECTION, SOLUTION1227
0409-7809-24Dopamine Hydrochloride in Dextrose12 in 1 CARTONINJECTION, SOLUTION1227
0409-7809-31Dopamine Hydrochloride in Dextrose500 mL in 1 BAGINJECTION, SOLUTION50027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7809-11ML - Milliliter0409-78090f5f70dd-c881-4534-ba67-7b1e9245d94c12019-08-06
0409-7809-22ML - Milliliter0409-780933d938a5-3c98-4dcc-9057-f90b1eaefc6d12013-02-13
0409-7809-24ML - Milliliter0409-78092c6e271f-0637-4254-bef2-50809e099c0912013-02-13
0409-7809-31ML - Milliliter0409-7809224c8f8e-53f6-489b-8d4c-e7b669bc797812019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOPAMINE HYDROCHLORIDEACTIVE INGREDIENT7L3E358N9LDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
DOPAMINEACTIVE MOIETYVTD58H1Z2XDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
DEXTROSE MONOHYDRATEINACTIVE INGREDIENTLX22YL083GDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12
WATERINACTIVE INGREDIENT059QF0KO0RDOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7809DOPAMINE HYDROCHLORIDE IN DEXTROSE INJECTION, SOLUTION [HOSPIRA, INC.]23Current NDC, Legacy NDC, 4 package rows20241127_08f23f6e-150d-45ea-098e-f2edf64c21a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879DOPamine HCl 1600 MCG/ML in 500 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887DOPamine HCl 3200 MCG/ML in 250 ML InjectionPSN08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887250 ML dopamine hydrochloride 3.2 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879500 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1743879dopamine HCl 1600 MCG/ML per 500 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1292887dopamine HCl 3200 MCG/ML per 250 ML InjectionSY08f23f6e-150d-45ea-098e-f2edf64c21a127
1743877DOPamine HCl 1600 MCG/ML in 250 ML InjectionPSN7896052c-2a72-ca89-e053-2a91aa0ae86e6
1743877250 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD7896052c-2a72-ca89-e053-2a91aa0ae86e6
1743877dopamine HCl 1600 MCG/ML per 250 ML InjectionSY7896052c-2a72-ca89-e053-2a91aa0ae86e6
1743879DOPamine HCl 1600 MCG/ML in 500 ML InjectionPSN9989b253-dcf5-7318-e053-2995a90a28903
1743879500 ML dopamine hydrochloride 1.6 MG/ML InjectionSCD9989b253-dcf5-7318-e053-2995a90a28903
1743879dopamine HCl 1600 MCG/ML per 500 ML InjectionSY9989b253-dcf5-7318-e053-2995a90a28903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7809-1100409780911250 mL in 1 BAG250 mlHistorical
0409-7809-220040978092212 BAG in 1 CARTON (0409-7809-22) > 250 mL in 1 BAG (0409-7809-11) 12 bag2005-04-300000-00-00NoNoCurrent
0409-7809-240040978092412 BAG in 1 CARTON (0409-7809-24) / 500 mL in 1 BAG (0409-7809-31) 12 bag2005-10-140000-00-00NoNoCurrent
0409-7809-3100409780931500 mL in 1 BAG500 mlHistorical