PROPOFOL

Product NDC
0409-6010
11-digit product format
004096010
Labeler code
0409
Product ID
0409-6010_6b15a686-96ff-4f19-8638-bce64d91e266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPOFOL
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA077908
Marketing category
ANDA
Marketing start
2022-05-22
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-6010-02PROPOFOL20 mL in 1 VIALINJECTION, EMULSION2025
0409-6010-25PROPOFOL25 in 1 TRAYINJECTION, EMULSION2525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6010-02ML - Milliliter0409-6010717a4107-3afd-4f14-8944-9eae8accfbbc12022-06-06
0409-6010-25ML - Milliliter0409-60102f62d5e3-413f-4672-8cbf-01bb18e022f912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPOFOLACTIVE INGREDIENTYI7VU623SFPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
PROPOFOLACTIVE MOIETYYI7VU623SFPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6
SOYBEAN OILINACTIVE INGREDIENT241ATL177APROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-6010PROPOFOL INJECTION, EMULSION [HOSPIRA, INC.]22Current NDC, Legacy NDC, 2 package rows20241206_28d7ba00-f824-4e55-139a-03f509c099db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808224propofol 200 MG in 20 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808222propofol 500 MG in 50 ML InjectionPSN28d7ba00-f824-4e55-139a-03f509c099db25
1808217100 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
180822420 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
180822250 ML propofol 10 MG/ML InjectionSCD28d7ba00-f824-4e55-139a-03f509c099db25
1808217propofol 1000 MG per 100 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25
1808224propofol 200 MG per 20 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25
1808222propofol 500 MG per 50 ML InjectionSY28d7ba00-f824-4e55-139a-03f509c099db25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-6010-020040960100220 mL in 1 VIAL20 mlHistorical
0409-6010-250040960102525 VIAL in 1 TRAY (0409-6010-25) / 20 mL in 1 VIAL (0409-6010-02) 25 vial2022-05-220000-00-00NoNoCurrent