topcare anti diarrheal (36800-224)

Drug Facts

Product Profile

Brand Name topcare anti diarrheal

Generic Name loperamide hydrochloride

Labeler topco associates llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer

Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-224

Product ID 36800-224_1d9293db-7ead-4316-a8a3-2c5ff664772c

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA075232

Listing Expiration 2026-12-31

Marketing Start 2003-02-26

Pharmacologic Class

Classes

opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800224

Hyphenated Format 36800-224

Supplemental Identifiers

RxCUI

978010

UNII

77TI35393C

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name topcare anti diarrheal (source: ndc)

Generic Name loperamide hydrochloride (source: ndc)

Application Number ANDA075232 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

2 mg/1

source: ndc

Packaging

12 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK
24 BLISTER PACK in 1 CARTON (36800-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
6 BLISTER PACK in 1 CARTON (36800-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK

source: ndc

Packages (3)

36800-224-53 12 BLISTER PACK in 1 CARTON (36800-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK 36800-224-62 24 BLISTER PACK in 1 CARTON (36800-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK 36800-224-91 6 BLISTER PACK in 1 CARTON (36800-224-91) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

topcare anti diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

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