Sufentanil Citrate

Product NDC
0641-6112
11-digit product format
006416112
Labeler code
0641
Product ID
0641-6112_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
0641-6112-01ML - Milliliter0641-6112e37d1b09-fe67-418d-a174-d0f435815cd212012-07-24
0641-6112-10ML - Milliliter0641-61125078267c-0c4e-439c-b41f-99ac478624dd12012-07-24

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
0641-6112SUFENTANIL 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
0641-6112-100064161121010 AMPULE in 1 CARTON (0641-6112-10) > 5 mL in 1 AMPULE (0641-6112-01) 10 ampule1995-12-150000-00-00NoNoCurrent