FDA.reportPublic FDA data

PROPOFOL

Product NDC
0641-6196
11-digit product format
006416196
Labeler code
0641
Product ID
0641-6196_113ac304-ef02-4891-ac8b-8788f4ea041c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPOFOL
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074848
Marketing category
ANDA
Marketing start
2020-05-01
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPOFOL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYI7VU623SF
Rxcui1808217, 1808222, 1808224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6196-01PROPOFOL100 mL in 1 VIAL, SINGLE-USEINJECTION, EMULSION1003
0641-6196-10PROPOFOL10 in 1 CARTONINJECTION, EMULSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6196-01ML - Milliliter0641-6196e0bc536f-5758-4042-98da-1aae349cdf6512020-05-08
0641-6196-10ML - Milliliter0641-61967e45065c-1c80-4ebe-9c09-c45d2ff444a712020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6196PROPOFOL INJECTION, EMULSION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20230124_fdb77e13-f5a7-4c4a-9f8e-338b702239c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSNfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808224propofol 200 MG in 20 ML InjectionPSNfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808222propofol 500 MG in 50 ML InjectionPSNfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808217100 ML propofol 10 MG/ML InjectionSCDfdb77e13-f5a7-4c4a-9f8e-338b702239c83
180822420 ML propofol 10 MG/ML InjectionSCDfdb77e13-f5a7-4c4a-9f8e-338b702239c83
180822250 ML propofol 10 MG/ML InjectionSCDfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808217propofol 1000 MG per 100 ML InjectionSYfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808224propofol 200 MG per 20 ML InjectionSYfdb77e13-f5a7-4c4a-9f8e-338b702239c83
1808222propofol 500 MG per 50 ML InjectionSYfdb77e13-f5a7-4c4a-9f8e-338b702239c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6196-0100641619601100 mL in 1 VIAL, SINGLE-USE100 mlHistorical
0641-6196-100064161961010 VIAL, SINGLE-USE in 1 CARTON (0641-6196-10) / 100 mL in 1 VIAL, SINGLE-USE (0641-6196-01) 2020-05-010000-00-00NoNoCurrent