temazepam
Temazepam
Approved
Approval ID
09abc9b1-50fc-4c60-a6a1-9772e35b057a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
temazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-283
Application NumberANDA071457
Product Classification
M
Marketing Category
C73584
G
Generic Name
temazepam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2009
FDA Product Classification
INGREDIENTS (21)
temazepamActive
Quantity: 30 mg in 1 1
Code: CHB1QD2QSS
Classification: ACTIB
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
edetate calcium disodiumInactive
Code: 25IH6R4SGF
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
butylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
sodium propionateInactive
Code: DK6Y9P42IN
Classification: IACT
ammoniaInactive
Code: 5138Q19F1X
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT