Diphenoxylate Hydrochloride and Atropine Sulfate
Diphenoxylate Hydrochloride
Approved
Approval ID
787f49c7-3726-4eee-87f0-0d6ab8fc5f3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 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.
diphenoxylate hydrochloride and atropine sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-688
Application NumberANDA085762
Product Classification
M
Marketing Category
C73584
G
Generic Name
diphenoxylate hydrochloride and atropine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2009
FDA Product Classification
INGREDIENTS (6)
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB