Promethazine hydrochloride
Promethazine Hydrochloride Tablets USP Revised: January 2005 Rx only
Approved
Approval ID
23a83c87-ad92-46af-aeed-12e93ab3255d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 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.
Promethazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-453
Application NumberANDA083426
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2006
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Promethazine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
Stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT