FDA.reportPublic FDA data

propofol

Product NDC
16714-528
11-digit product format
167140528
Labeler code
16714
Product ID
16714-528_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA206408
Marketing category
ANDA
Marketing start
2022-07-01
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
16714-528-01propofol20 mL in 1 VIALINJECTION, EMULSION205
16714-528-10propofol10 in 1 CARTONINJECTION, EMULSION105
16714-528-20propofol20 in 1 CARTONINJECTION, EMULSION205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-528-01ML - Milliliter16714-528042e6926-96c7-4cdf-82e9-4779a5ac774612022-09-12
16714-528-10ML - Milliliter16714-528867e43f4-0b22-4c73-8510-e1ca3dbedc9e12022-09-12
16714-528-20ML - Milliliter16714-528ed6e5f06-ee76-4e79-b035-6a40f325807c12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-528PROPOFOL INJECTION, EMULSION [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 3 package rows20241207_5ec25932-6c21-4cd5-8f60-80761f2e20a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808224propofol 200 MG in 20 ML InjectionPSN5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808222propofol 500 MG in 50 ML InjectionPSN5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808217100 ML propofol 10 MG/ML InjectionSCD5ec25932-6c21-4cd5-8f60-80761f2e20a65
180822420 ML propofol 10 MG/ML InjectionSCD5ec25932-6c21-4cd5-8f60-80761f2e20a65
180822250 ML propofol 10 MG/ML InjectionSCD5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808217propofol 1000 MG per 100 ML InjectionSY5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808224propofol 200 MG per 20 ML InjectionSY5ec25932-6c21-4cd5-8f60-80761f2e20a65
1808222propofol 500 MG per 50 ML InjectionSY5ec25932-6c21-4cd5-8f60-80761f2e20a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-528-011671405280120 mL in 1 VIAL20 mlHistorical
16714-528-101671405281010 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01) 10 vial2022-07-010000-00-00NoNoCurrent
16714-528-201671405282020 VIAL in 1 CARTON (16714-528-20) / 20 mL in 1 VIAL (16714-528-01) 20 vial2022-07-010000-00-00NoNoCurrent