propofol

Product NDC
71288-729
11-digit product format
712880729
Labeler code
71288
Product ID
71288-729_98e25b4f-43c4-4269-8213-aacb02a75099
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA217945
Marketing category
ANDA
Marketing start
2025-12-02
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
71288-729-20propofol20 mL in 1 VIALINJECTION, EMULSION203
71288-729-21propofol10 in 1 CARTONINJECTION, EMULSION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-729-20ML - Milliliter71288-729c5d77adb-8a24-4a09-aa20-899b67ed0c3712026-04-20
71288-729-21ML - Milliliter71288-72932f1178e-dffc-47e9-8ae8-88e3255be4f112026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808224propofol 200 MG in 20 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808222propofol 500 MG in 50 ML InjectionPSN548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808217100 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
180822420 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
180822250 ML propofol 10 MG/ML InjectionSCD548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808217propofol 1000 MG per 100 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808224propofol 200 MG per 20 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53
1808222propofol 500 MG per 50 ML InjectionSY548d5192-2e5e-4c1b-8f17-940b6e791ae53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-729-207128807292020 mL in 1 VIAL20 mlHistorical
71288-729-217128807292110 VIAL in 1 CARTON (71288-729-21) / 20 mL in 1 VIAL (71288-729-20) 10 vial2025-12-02NoNoCurrent