propofol

Generic: propofol

Labeler: amneal pharmaceuticals private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propofol
Generic Name propofol
Labeler amneal pharmaceuticals private limited
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

propofol 10 mg/mL

Manufacturer
Amneal Pharmaceuticals Private Limited

Identifiers & Regulatory

Product NDC 80830-1188
Product ID 80830-1188_37f0add8-759a-4ec9-a147-edef685124e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217525
Listing Expiration 2026-12-31
Marketing Start 2024-08-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 808301188
Hyphenated Format 80830-1188

Supplemental Identifiers

RxCUI
1808217 1808222 1808224
UPC
0380830118817 0380830236573 0380830236511 0380830118879
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 ANDA217525 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (80830-1188-7) / 20 mL in 1 VIAL (80830-1188-1)
source: ndc

Packages (1)

80830-1188-7 10 VIAL in 1 CARTON (80830-1188-7) / 20 mL in 1 VIAL (80830-1188-1)

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": "37f0add8-759a-4ec9-a147-edef685124e5", "openfda": {"nui": ["N0000175975", "N0000175681"], "upc": ["0380830118817", "0380830236573", "0380830236511", "0380830118879"], "unii": ["YI7VU623SF"], "rxcui": ["1808217", "1808222", "1808224"], "spl_set_id": ["6833edd6-ba8a-4b97-a872-ab253c64a903"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals Private Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (80830-1188-7)  / 20 mL in 1 VIAL (80830-1188-1)", "package_ndc": "80830-1188-7", "marketing_start_date": "20240816"}], "brand_name": "PROPOFOL", "product_id": "80830-1188_37f0add8-759a-4ec9-a147-edef685124e5", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "80830-1188", "generic_name": "propofol", "labeler_name": "Amneal Pharmaceuticals Private Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROPOFOL", "active_ingredients": [{"name": "PROPOFOL", "strength": "10 mg/mL"}], "application_number": "ANDA217525", "marketing_category": "ANDA", "marketing_start_date": "20240816", "listing_expiration_date": "20261231"}