FDA.reportPublic FDA data

Propofol

Product NDC
83634-603
11-digit product format
836340603
Labeler code
83634
Product ID
83634-603_fae91f1b-7be7-4f48-9541-ee9f2a56a40a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Avenacy, LLC
Application
ANDA206408
Marketing category
ANDA
Marketing start
2025-03-30
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
83634-603-20Propofol20 in 1 CARTONINJECTION, EMULSION202
83634-603-41Propofol20 mL in 1 VIALINJECTION, EMULSION202
83634-603-42Propofol50 mL in 1 VIALINJECTION, EMULSION502
83634-603-43Propofol100 mL in 1 VIALINJECTION, EMULSION1002
83634-603-50Propofol20 in 1 CARTONINJECTION, EMULSION202
83634-603-51Propofol10 in 1 CARTONINJECTION, EMULSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83634-603-20ML - Milliliter83634-60330a86197-219d-4a66-8e61-5f78c7ec314a12025-05-14
83634-603-43ML - Milliliter83634-603d6fd079e-87fb-4027-8cd6-d015c86d016312025-05-14
83634-603-50ML - Milliliter83634-603007b61e7-d3ac-4f09-8f13-d470ae58550c12025-05-14
83634-603-51ML - Milliliter83634-6036994dd9d-4517-4661-877e-541fcef3de5b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83634-603PROPOFOL INJECTION, EMULSION [AVENACY INC.]1Current NDC, 6 package rows20250115_de351d5f-581d-4768-a4af-fbd8e5bce264.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSNde351d5f-581d-4768-a4af-fbd8e5bce2642
1808224propofol 200 MG in 20 ML InjectionPSNde351d5f-581d-4768-a4af-fbd8e5bce2642
1808222propofol 500 MG in 50 ML InjectionPSNde351d5f-581d-4768-a4af-fbd8e5bce2642
1808217100 ML propofol 10 MG/ML InjectionSCDde351d5f-581d-4768-a4af-fbd8e5bce2642
180822420 ML propofol 10 MG/ML InjectionSCDde351d5f-581d-4768-a4af-fbd8e5bce2642
180822250 ML propofol 10 MG/ML InjectionSCDde351d5f-581d-4768-a4af-fbd8e5bce2642
1808217propofol 1000 MG per 100 ML InjectionSYde351d5f-581d-4768-a4af-fbd8e5bce2642
1808224propofol 200 MG per 20 ML InjectionSYde351d5f-581d-4768-a4af-fbd8e5bce2642
1808222propofol 500 MG per 50 ML InjectionSYde351d5f-581d-4768-a4af-fbd8e5bce2642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83634-603-208363406032020 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41) 20 vial2025-04-30NoNoHistorical
83634-603-418363406034120 mL in 1 VIAL20 mlHistorical
83634-603-428363406034250 mL in 1 VIAL50 mlHistorical
83634-603-4383634060343100 mL in 1 VIAL100 mlHistorical
83634-603-508363406035020 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42) 20 vial2025-04-30NoNoHistorical
83634-603-518363406035110 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43) 10 vial2025-04-30NoNoHistorical