FDA.reportPublic FDA data

propofol

Product NDC
23155-345
11-digit product format
231550345
Labeler code
23155
Product ID
23155-345_e7991b6c-43de-45f6-9105-bb03c7eaddf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA206408
Marketing category
ANDA
Marketing start
2021-10-12
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
23155-345-31propofol20 mL in 1 VIALINJECTION, EMULSION2014
23155-345-32propofol50 mL in 1 VIALINJECTION, EMULSION5014
23155-345-33propofol100 mL in 1 VIALINJECTION, EMULSION10014
23155-345-41propofol10 in 1 CARTONINJECTION, EMULSION1014
23155-345-42propofol20 in 1 CARTONINJECTION, EMULSION2014
23155-345-43propofol10 in 1 CARTONINJECTION, EMULSION1014
23155-345-44propofol20 in 1 CARTONINJECTION, EMULSION2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-345-31ML - Milliliter23155-345a26e1740-ef76-4599-8b17-22a3bb4e093d12022-03-09
23155-345-32ML - Milliliter23155-34531e732a5-fc5e-4d34-b064-b836fa1b776912022-03-09
23155-345-33ML - Milliliter23155-345e52424e0-ee90-4b7b-8283-62c53c4f833412022-03-09
23155-345-41ML - Milliliter23155-345111f6db1-d98a-40af-ba2d-103630ea797512022-06-06
23155-345-42ML - Milliliter23155-345def5dfb2-e2bb-4481-a953-15ebec15a90e12022-03-09
23155-345-43ML - Milliliter23155-34503591549-ee93-4ec6-aea2-fe9ba618211f12022-03-09
23155-345-44ML - Milliliter23155-345afc56d8a-0a40-4f20-9841-dbd2ce0fb4e512022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-345PROPOFOL INJECTION, EMULSION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 7 package rows20241215_10272dc1-657d-4798-a34a-b6341b92e560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN10272dc1-657d-4798-a34a-b6341b92e56014
1808224propofol 200 MG in 20 ML InjectionPSN10272dc1-657d-4798-a34a-b6341b92e56014
1808222propofol 500 MG in 50 ML InjectionPSN10272dc1-657d-4798-a34a-b6341b92e56014
1808217100 ML propofol 10 MG/ML InjectionSCD10272dc1-657d-4798-a34a-b6341b92e56014
180822420 ML propofol 10 MG/ML InjectionSCD10272dc1-657d-4798-a34a-b6341b92e56014
180822250 ML propofol 10 MG/ML InjectionSCD10272dc1-657d-4798-a34a-b6341b92e56014
1808217propofol 1000 MG per 100 ML InjectionSY10272dc1-657d-4798-a34a-b6341b92e56014
1808224propofol 200 MG per 20 ML InjectionSY10272dc1-657d-4798-a34a-b6341b92e56014
1808222propofol 500 MG per 50 ML InjectionSY10272dc1-657d-4798-a34a-b6341b92e56014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-345-312315503453120 mL in 1 VIAL20 mlHistorical
23155-345-322315503453250 mL in 1 VIAL50 mlHistorical
23155-345-3323155034533100 mL in 1 VIAL100 mlHistorical
23155-345-412315503454110 VIAL in 1 CARTON (23155-345-41) / 20 mL in 1 VIAL (23155-345-31) 10 vial2025-06-020000-00-00NoNoCurrent
23155-345-422315503454220 VIAL in 1 CARTON (23155-345-42) / 50 mL in 1 VIAL (23155-345-32) 20 vial2025-06-020000-00-00NoNoCurrent
23155-345-432315503454310 VIAL in 1 CARTON (23155-345-43) / 100 mL in 1 VIAL (23155-345-33) 10 vial2025-06-020000-00-00NoNoCurrent
23155-345-442315503454420 VIAL in 1 CARTON (23155-345-44) / 20 mL in 1 VIAL (23155-345-31) 20 vial2025-06-020000-00-00NoNoCurrent