anti-diarrheal

Generic: loperamide hydrochloride

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hydrochloride
Labeler top care (topco associates llc)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-208
Product ID 36800-208_f10fa51b-9cb9-502a-e053-2995a90a11d1
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA021855
Listing Expiration 2026-12-31
Marketing Start 2021-07-02

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800208
Hyphenated Format 36800-208

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
  • 2 BLISTER PACK in 1 CARTON (36800-208-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

36800-208-12 2 BLISTER PACK in 1 CARTON (36800-208-12) / 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": "f10fa51b-9cb9-502a-e053-2995a90a11d1", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["c62bc8d4-0857-16fc-e053-2a95a90a0c41"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (36800-208-12)  / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "36800-208-12", "marketing_start_date": "20210702"}], "brand_name": "Anti-Diarrheal", "product_id": "36800-208_f10fa51b-9cb9-502a-e053-2995a90a11d1", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "36800-208", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "TOP CARE (Topco Associates LLC)", "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": "20210702", "listing_expiration_date": "20261231"}