propofol

Generic: propofol

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propofol
Generic Name propofol
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

propofol 10 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6196
Product ID 0641-6196_113ac304-ef02-4891-ac8b-8788f4ea041c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074848
Listing Expiration 2026-12-31
Marketing Start 2020-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416196
Hyphenated Format 0641-6196

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 ANDA074848 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (0641-6196-10) / 100 mL in 1 VIAL, SINGLE-USE (0641-6196-01)
source: ndc

Packages (1)

0641-6196-10 10 VIAL, SINGLE-USE in 1 CARTON (0641-6196-10) / 100 mL in 1 VIAL, SINGLE-USE (0641-6196-01)

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": "113ac304-ef02-4891-ac8b-8788f4ea041c", "openfda": {"nui": ["N0000175975", "N0000175681"], "unii": ["YI7VU623SF"], "rxcui": ["1808217", "1808222", "1808224"], "spl_set_id": ["fdb77e13-f5a7-4c4a-9f8e-338b702239c8"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (0641-6196-10)  / 100 mL in 1 VIAL, SINGLE-USE (0641-6196-01)", "package_ndc": "0641-6196-10", "marketing_start_date": "20200501"}], "brand_name": "PROPOFOL", "product_id": "0641-6196_113ac304-ef02-4891-ac8b-8788f4ea041c", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "0641-6196", "generic_name": "PROPOFOL", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROPOFOL", "active_ingredients": [{"name": "PROPOFOL", "strength": "10 mg/mL"}], "application_number": "ANDA074848", "marketing_category": "ANDA", "marketing_start_date": "20200501", "listing_expiration_date": "20261231"}