Diphenoxylate Hydrochloride and Atropine Sulfate
Approved
Approval ID
869392b7-47cc-4e26-8d1a-6b96c0503916
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0032
Application NumberANDA085762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diphenoxylate Hydrochloride and Atropine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2011
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ATROPINE SULFATEActive
Quantity: 0.025 mg in 1 1
Code: 03J5ZE7KA5
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIPHENOXYLATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: W24OD7YW48
Classification: ACTIB