propofol

Generic: propofol

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

propofol 10 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-528
Product ID 16714-528_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206408
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714528
Hyphenated Format 16714-528

Supplemental Identifiers

RxCUI
1808217 1808222 1808224
UPC
0316714528014 0316714690018
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
  • 10 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01)
  • 20 VIAL in 1 CARTON (16714-528-20) / 20 mL in 1 VIAL (16714-528-01)
source: ndc

Packages (2)

16714-528-10 10 VIAL in 1 CARTON (16714-528-10) / 20 mL in 1 VIAL (16714-528-01) 16714-528-20 20 VIAL in 1 CARTON (16714-528-20) / 20 mL in 1 VIAL (16714-528-01)

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": "d7b2f7ed-e91e-430a-bab2-a9533b90e8b9", "openfda": {"nui": ["N0000175975", "N0000175681"], "upc": ["0316714528014", "0316714690018"], "unii": ["YI7VU623SF"], "rxcui": ["1808217", "1808222", "1808224"], "spl_set_id": ["5ec25932-6c21-4cd5-8f60-80761f2e20a6"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (16714-528-10)  / 20 mL in 1 VIAL (16714-528-01)", "package_ndc": "16714-528-10", "marketing_start_date": "20220701"}, {"sample": false, "description": "20 VIAL in 1 CARTON (16714-528-20)  / 20 mL in 1 VIAL (16714-528-01)", "package_ndc": "16714-528-20", "marketing_start_date": "20220701"}], "brand_name": "propofol", "product_id": "16714-528_d7b2f7ed-e91e-430a-bab2-a9533b90e8b9", "dosage_form": "INJECTION, EMULSION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "16714-528", "generic_name": "propofol", "labeler_name": "NorthStar Rx 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": "20220701", "listing_expiration_date": "20261231"}