anti-diarrheal

Generic: loperamide hydrochloride

Labeler: chain drug marketing association inc.
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hydrochloride
Labeler chain drug marketing association inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC.

Identifiers & Regulatory

Product NDC 63868-876
Product ID 63868-876_f05dd9d9-e5a3-61ab-e053-2a95a90acbe0
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021855
Listing Expiration 2026-12-31
Marketing Start 2019-01-25

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63868876
Hyphenated Format 63868-876

Supplemental Identifiers

RxCUI
978006
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 anti-diarrheal (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number NDA021855 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (63868-876-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (63868-876-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (2)

63868-876-12 1 BLISTER PACK in 1 CARTON (63868-876-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 63868-876-24 2 BLISTER PACK in 1 CARTON (63868-876-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

Anti-Diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f05dd9d9-e5a3-61ab-e053-2a95a90acbe0", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["edae1ea7-7a6a-4971-8a21-c2b508e96f4e"], "manufacturer_name": ["CHAIN DRUG MARKETING ASSOCIATION INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (63868-876-12)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "63868-876-12", "marketing_start_date": "20190125"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (63868-876-24)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "63868-876-24", "marketing_start_date": "20190125"}], "brand_name": "Anti-Diarrheal", "product_id": "63868-876_f05dd9d9-e5a3-61ab-e053-2a95a90acbe0", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "63868-876", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "CHAIN DRUG MARKETING ASSOCIATION INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-Diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "NDA021855", "marketing_category": "NDA", "marketing_start_date": "20190125", "listing_expiration_date": "20261231"}