FDA.reportPublic FDA data

Dopram

Product NDC
0641-6018
11-digit product format
006416018
Labeler code
0641
Product ID
0641-6018_ccb9f1b7-b7b1-4db2-b5db-093d147529a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxapram hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA014879
Marketing category
NDA
Marketing start
1965-06-23
Substance
DOXAPRAM HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Increased Medullary Respiratory Drive [PE], Respiratory Stimulant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAPRAM HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP5RU6UOQ5Y
Rxcui1047087, 1047511

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fed9301-0c64-3f05-8673-b9784e7ea65aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6018-01Dopram20 mL in 1 VIALINJECTION206
0641-6018-06Dopram6 in 1 CARTONINJECTION66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6018-01ML - Milliliter0641-601828e7dea2-29ed-475f-bafc-3a075b8ae61212012-07-24
0641-6018-06ML - Milliliter0641-6018e51b6f70-f3ce-484b-8fbd-931ddb64ec1112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXAPRAM HYDROCHLORIDEACTIVE INGREDIENTP5RU6UOQ5YDOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
DOXAPRAMACTIVE MOIETY94F3830Q73DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RDOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6018DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20240410_b8eb330a-a75b-46cb-b694-5be9327ed2eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047511Dopram 400 MG in 20 ML Injectable SolutionPSNb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047087doxapram HCl 400 MG in 20 ML Injectable SolutionPSNb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047511doxapram hydrochloride 20 MG/ML Injectable Solution [Dopram]SBDb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047087doxapram hydrochloride 20 MG/ML Injectable SolutionSCDb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047511Dopram 20 MG/ML Injectable SolutionSYb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047511Dopram 400 MG per 20 ML Injectable SolutionSYb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047511DOPRAM-V 20 MG/ML Injectable SolutionSYb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047087doxapram HCl 400 MG per 20 ML Injectable SolutionSYb8eb330a-a75b-46cb-b694-5be9327ed2eb6
1047087doxapram HCl 400 MG in 20 ML Injectable SolutionPSN954859c0-a121-34d6-e053-2a95a90a1e193
1047087doxapram hydrochloride 20 MG/ML Injectable SolutionSCD954859c0-a121-34d6-e053-2a95a90a1e193
1047087doxapram HCl 400 MG per 20 ML Injectable SolutionSY954859c0-a121-34d6-e053-2a95a90a1e193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6018-010064160180120 mL in 1 VIAL (0641-6018-01) 20 ml1965-06-230000-00-00NoNoCurrent
0641-6018-06006416018066 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01) 6 vial1965-06-230000-00-00NoNoCurrent