propofol injectable emulsion

Generic: propofol injectable emulsion

Labeler: dr. reddy's laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name propofol injectable emulsion
Generic Name propofol injectable emulsion
Labeler dr. reddy's laboratories, inc.
Dosage Form INJECTION, EMULSION
Routes
INTRAVENOUS
Active Ingredients

propofol 10 mg/mL

Manufacturer
Dr. Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-549
Product ID 43598-549_b4a9147e-dfe3-229a-d8d7-6a84e6449f15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205067
Listing Expiration 2026-12-31
Marketing Start 2018-11-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598549
Hyphenated Format 43598-549

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 injectable emulsion (source: ndc)
Generic Name propofol injectable emulsion (source: ndc)
Application Number ANDA205067 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (43598-549-10) / 100 mL in 1 VIAL (43598-549-52)
source: ndc

Packages (1)

43598-549-10 10 VIAL in 1 CARTON (43598-549-10) / 100 mL in 1 VIAL (43598-549-52)

Ingredients (1)

propofol (10 mg/mL)

Linked Drug Pages (1)

Propofol Injectable Emulsion ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b4a9147e-dfe3-229a-d8d7-6a84e6449f15", "openfda": {"nui": ["N0000175975", "N0000175681"], "unii": ["YI7VU623SF"], "rxcui": ["1808217", "1808222", "1808224"], "spl_set_id": ["800646b8-83a8-01d9-3dc8-bb2ddcb8570c"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Dr. Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (43598-549-10)  / 100 mL in 1 VIAL (43598-549-52)", "package_ndc": "43598-549-10", "marketing_start_date": "20181115"}], "brand_name": "Propofol Injectable Emulsion", "product_id": "43598-549_b4a9147e-dfe3-229a-d8d7-6a84e6449f15", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "43598-549", "generic_name": "Propofol Injectable Emulsion", "labeler_name": "Dr. Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Propofol Injectable Emulsion", "active_ingredients": [{"name": "PROPOFOL", "strength": "10 mg/mL"}], "application_number": "ANDA205067", "marketing_category": "ANDA", "marketing_start_date": "20181115", "listing_expiration_date": "20261231"}