Sufentanil Citrate

Product NDC
0641-6111
11-digit product format
006416111
Labeler code
0641
Product ID
0641-6111_469744fe-e76e-488f-acb4-57a75ecb4f59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sufentanil Citrate
Dosage form
INJECTION
Route
EPIDURAL; INTRAVENOUS
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA074413
Marketing category
ANDA
Marketing start
1995-12-15
Marketing end
0000-00-00
Substance
SUFENTANIL CITRATE
Active strength
0 mg/mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6111-01ML - Milliliter0641-6111de2ad8df-fd2d-4062-b58b-99d176f183d812012-07-24
0641-6111-10ML - Milliliter0641-6111bd6eea44-7395-4199-910f-c680f0a9d80912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUFENTANIL CITRATEACTIVE INGREDIENTS9ZFX8403RSUFENTANIL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
SUFENTANILACTIVE MOIETYAFE2YW0IIZSUFENTANIL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUFENTANIL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
WATERINACTIVE INGREDIENT059QF0KO0RSUFENTANIL CITRATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6111SUFENTANIL CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Legacy NDC20240412_52fc28b9-464a-4173-9d0d-000ed0dbf265.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6111-100064161111010 AMPULE in 1 CARTON (0641-6111-10) > 2 mL in 1 AMPULE (0641-6111-01) 10 ampule1995-12-150000-00-00NoNoCurrent