FDA.reportPublic FDA data

PROPOFOL

Product NDC
80830-2365
11-digit product format
808302365
Labeler code
80830
Product ID
80830-2365_37f0add8-759a-4ec9-a147-edef685124e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals Private Limited
Application
ANDA217525
Marketing category
ANDA
Marketing start
2024-08-16
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
80830-2365-1PROPOFOL100 mL in 1 VIALINJECTION, EMULSION1005
80830-2365-7PROPOFOL10 in 1 CARTONINJECTION, EMULSION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80830-2365-1ML - Milliliter80830-2365d8f1da4f-f306-4f4a-a07e-b6c076a4182f12025-01-14
80830-2365-7ML - Milliliter80830-2365ae8bb1a0-1a7a-4265-a915-5c4942492b7a12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80830-2365PROPOFOL INJECTION, EMULSION [AMNEAL PHARMACEUTICALS PRIVATE LIMITED]5Current NDC, 2 package rows20250522_6833edd6-ba8a-4b97-a872-ab253c64a903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808217propofol 1000 MG in 100 ML InjectionPSN6833edd6-ba8a-4b97-a872-ab253c64a9035
1808224propofol 200 MG in 20 ML InjectionPSN6833edd6-ba8a-4b97-a872-ab253c64a9035
1808222propofol 500 MG in 50 ML InjectionPSN6833edd6-ba8a-4b97-a872-ab253c64a9035
1808217100 ML propofol 10 MG/ML InjectionSCD6833edd6-ba8a-4b97-a872-ab253c64a9035
180822420 ML propofol 10 MG/ML InjectionSCD6833edd6-ba8a-4b97-a872-ab253c64a9035
180822250 ML propofol 10 MG/ML InjectionSCD6833edd6-ba8a-4b97-a872-ab253c64a9035
1808217propofol 1000 MG per 100 ML InjectionSY6833edd6-ba8a-4b97-a872-ab253c64a9035
1808224propofol 200 MG per 20 ML InjectionSY6833edd6-ba8a-4b97-a872-ab253c64a9035
1808222propofol 500 MG per 50 ML InjectionSY6833edd6-ba8a-4b97-a872-ab253c64a9035

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80830-2365-180830236501100 mL in 1 VIAL100 mlHistorical
80830-2365-78083023650710 VIAL in 1 CARTON (80830-2365-7) / 100 mL in 1 VIAL (80830-2365-1) 10 vial2024-08-16NoNoCurrent