Sufentanil Citrate

Generic: Sufentanil Citrate

Labeler: Hikma Pharmaceuticals USA Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Sufentanil Citrate
Generic Name Sufentanil Citrate
Labeler Hikma Pharmaceuticals USA Inc.
Dosage Form INJECTION
Routes
EPIDURAL INTRAVENOUS
Active Ingredients

SUFENTANIL CITRATE .05 mg/mL

Identifiers & Regulatory

Product NDC 0641-6112
Product ID 0641-6112_638c3fcf-1395-4d3b-885a-a16af800dc9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074413
DEA Schedule CII
Listing Expiration 2026-12-31
Marketing Start 1995-12-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06416112
Hyphenated Format 0641-6112

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 Sufentanil Citrate (source: ndc)
Generic Name Sufentanil Citrate (source: ndc)
Application Number ANDA074413 (source: ndc)
Routes
EPIDURAL INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (0641-6112-10) / 5 mL in 1 AMPULE (0641-6112-01)
source: ndc

Packages (1)

0641-6112-10 10 AMPULE in 1 CARTON (0641-6112-10) / 5 mL in 1 AMPULE (0641-6112-01)

Ingredients (1)

SUFENTANIL CITRATE (.05 mg/mL)

Linked Drug Pages (1)

Sufentanil Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INTRAVENOUS"], "spl_id": "638c3fcf-1395-4d3b-885a-a16af800dc9d", "openfda": {"unii": ["S9ZFX8403R"], "rxcui": ["1809097", "1809102", "1809104"], "spl_set_id": ["52fc28b9-464a-4173-9d0d-000ed0dbf265"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (0641-6112-10)  / 5 mL in 1 AMPULE (0641-6112-01)", "package_ndc": "0641-6112-10", "marketing_start_date": "19951215"}], "brand_name": "Sufentanil Citrate", "product_id": "0641-6112_638c3fcf-1395-4d3b-885a-a16af800dc9d", "dosage_form": "INJECTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "0641-6112", "dea_schedule": "CII", "generic_name": "Sufentanil Citrate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sufentanil Citrate", "active_ingredients": [{"name": "SUFENTANIL CITRATE", "strength": ".05 mg/mL"}], "application_number": "ANDA074413", "marketing_category": "ANDA", "marketing_start_date": "19951215", "listing_expiration_date": "20261231"}