FDA Product

Loperamide Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Loperamide Hydrochloride

FDA Product Code

50090-0460

Regulatory Information

NDC Product Code

50090-0460

Application Number

ANDA073192

Marketing Category

C73584

Effective Date

November 30, 2016

Territorial Authority

USA

FDA Title

Loperamide Hydrochloride Capsules USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

11

Company Information

ManufacturerA-S Medication Solutions

DUNS Number

830016429

Active Ingredients

DIMETHICONE

Code: 92RU3N3Y1O

Class Code: IACT

LOPERAMIDE HYDROCHLORIDE

Quantity: 2 mg in 1 1

Code: 77TI35393C

Class Code: ACTIB

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

Active Moieties

LOPERAMIDE

Code: 6X9OC3H4II

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