FDA.reportPublic FDA data

Diprivan

Product NDC
65219-800
11-digit product format
652190800
Labeler code
65219
Product ID
65219-800_8d8838c0-3c0c-4732-ade1-12f76001c50b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPOFOL
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
NDA019627
Marketing category
NDA
Marketing start
2020-01-13
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
Diprivan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPOFOL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYI7VU623SF
Rxcui1808224, 1808225

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
65219-800-01Diprivan20 mL in 1 VIALINJECTION, EMULSION206
65219-800-10Diprivan10 in 1 CARTONINJECTION, EMULSION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-800DIPRIVAN (PROPOFOL) INJECTION, EMULSION [FRESENIUS KABI USA, LLC]6Current NDC, Legacy NDC, 2 package rows20240425_5cec3b97-5183-4a9d-accd-21e76c99d3dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808225DIPRIVAN 200 MG in 20 ML InjectionPSN5cec3b97-5183-4a9d-accd-21e76c99d3dd6
1808224propofol 200 MG in 20 ML InjectionPSN5cec3b97-5183-4a9d-accd-21e76c99d3dd6
180822520 ML propofol 10 MG/ML Injection [Diprivan]SBD5cec3b97-5183-4a9d-accd-21e76c99d3dd6
180822420 ML propofol 10 MG/ML InjectionSCD5cec3b97-5183-4a9d-accd-21e76c99d3dd6
180822520 ML Diprivan 10 MG/ML InjectionSY5cec3b97-5183-4a9d-accd-21e76c99d3dd6
1808225Diprivan 200 MG per 20 ML InjectionSY5cec3b97-5183-4a9d-accd-21e76c99d3dd6
1808224propofol 200 MG per 20 ML InjectionSY5cec3b97-5183-4a9d-accd-21e76c99d3dd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65219-800-016521908000120 mL in 1 VIAL20 mlHistorical
65219-800-106521908001010 VIAL in 1 CARTON (65219-800-10) / 20 mL in 1 VIAL (65219-800-01) 10 vial2020-01-130000-00-00NoNoCurrent