propofol

Generic: propofol

Labeler: avenacy, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propofol
Generic Name propofol
Labeler avenacy, llc
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

propofol 10 mg/mL

Manufacturer
Avenacy, LLC

Identifiers & Regulatory

Product NDC 83634-603
Product ID 83634-603_fae91f1b-7be7-4f48-9541-ee9f2a56a40a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206408
Listing Expiration 2026-12-31
Marketing Start 2025-03-30

Pharmacologic Class

Established (EPC)
general anesthetic [epc]
Physiologic Effect
general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634603
Hyphenated Format 83634-603

Supplemental Identifiers

RxCUI
1808217 1808222 1808224
UNII
YI7VU623SF
NUI
N0000175975 N0000175681

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name propofol (source: ndc)
Generic Name propofol (source: ndc)
Application Number ANDA206408 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 20 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41)
  • 20 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42)
  • 10 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43)
source: ndc

Packages (3)

83634-603-20 20 VIAL in 1 CARTON (83634-603-20) / 20 mL in 1 VIAL (83634-603-41) 83634-603-50 20 VIAL in 1 CARTON (83634-603-50) / 50 mL in 1 VIAL (83634-603-42) 83634-603-51 10 VIAL in 1 CARTON (83634-603-51) / 100 mL in 1 VIAL (83634-603-43)

Ingredients (1)

propofol (10 mg/mL)

Linked Drug Pages (1)

Propofol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fae91f1b-7be7-4f48-9541-ee9f2a56a40a", "openfda": {"nui": ["N0000175975", "N0000175681"], "unii": ["YI7VU623SF"], "rxcui": ["1808217", "1808222", "1808224"], "spl_set_id": ["de351d5f-581d-4768-a4af-fbd8e5bce264"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Avenacy, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 VIAL in 1 CARTON (83634-603-20)  / 20 mL in 1 VIAL (83634-603-41)", "package_ndc": "83634-603-20", "marketing_start_date": "20250430"}, {"sample": false, "description": "20 VIAL in 1 CARTON (83634-603-50)  / 50 mL in 1 VIAL (83634-603-42)", "package_ndc": "83634-603-50", "marketing_start_date": "20250430"}, {"sample": false, "description": "10 VIAL in 1 CARTON (83634-603-51)  / 100 mL in 1 VIAL (83634-603-43)", "package_ndc": "83634-603-51", "marketing_start_date": "20250430"}], "brand_name": "Propofol", "product_id": "83634-603_fae91f1b-7be7-4f48-9541-ee9f2a56a40a", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "83634-603", "generic_name": "propofol", "labeler_name": "Avenacy, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propofol", "active_ingredients": [{"name": "PROPOFOL", "strength": "10 mg/mL"}], "application_number": "ANDA206408", "marketing_category": "ANDA", "marketing_start_date": "20250330", "listing_expiration_date": "20261231"}