FDA.reportPublic FDA data

Propofol

Product NDC
72572-612
11-digit product format
725720612
Labeler code
72572
Product ID
72572-612_53af19df-7a6e-41e1-9fb1-1c5c20b1ec7b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Civica, Inc
Application
ANDA205576
Marketing category
ANDA
Marketing start
2021-07-16
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propofol
Listing expiration
2027-12-31

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
72572-612-01Propofol100 mL in 1 VIALINJECTION, EMULSION1007
72572-612-10Propofol10 in 1 CARTONINJECTION, EMULSION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-612-01ML - Milliliter72572-612ee4ed302-a8fd-47ac-b3b4-236ba62977af12021-10-08
72572-612-10ML - Milliliter72572-612ce845012-d60d-4db8-ae55-9d92239f4ea912021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-612PROPOFOL INJECTION, EMULSION [CIVICA, INC]5Current NDC, Legacy NDC, 2 package rows20230926_9ba70032-40c2-41c5-9f99-d1f94032d3dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808224propofol 200 MG in 20 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808222propofol 500 MG in 50 ML InjectionPSN9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808217100 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
180822420 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
180822250 ML propofol 10 MG/ML InjectionSCD9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808217propofol 1000 MG per 100 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808224propofol 200 MG per 20 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7
1808222propofol 500 MG per 50 ML InjectionSY9ba70032-40c2-41c5-9f99-d1f94032d3dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-612-0172572061201100 mL in 1 VIAL100 mlHistorical
72572-612-107257206121010 VIAL in 1 CARTON (72572-612-10) / 100 mL in 1 VIAL (72572-612-01) 10 vial2021-07-160000-00-00NoNoCurrent