anti-diarrheal

Generic: loperamide hcl

Labeler: chain drug consortium
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anti-diarrheal
Generic Name loperamide hcl
Labeler chain drug consortium
Dosage Form TABLET
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Chain Drug Consortium

Identifiers & Regulatory

Product NDC 68016-301
Product ID 68016-301_f05ff0cc-d7bd-45a9-8612-f20870c9668c
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076497
Marketing Start 2019-12-06
Marketing End 2026-11-30

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68016301
Hyphenated Format 68016-301

Supplemental Identifiers

RxCUI
978010
UPC
0840986036293
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 hcl (source: ndc)
Application Number ANDA076497 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (68016-301-18) / 6 TABLET in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (68016-301-24) / 6 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

68016-301-18 3 BLISTER PACK in 1 CARTON (68016-301-18) / 6 TABLET in 1 BLISTER PACK 68016-301-24 4 BLISTER PACK in 1 CARTON (68016-301-24) / 6 TABLET 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": "f05ff0cc-d7bd-45a9-8612-f20870c9668c", "openfda": {"upc": ["0840986036293"], "unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["1b82f4ce-0cf5-46d1-9894-9f1271b29569"], "manufacturer_name": ["Chain Drug Consortium"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68016-301-18)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "68016-301-18", "marketing_end_date": "20261130", "marketing_start_date": "20191206"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (68016-301-24)  / 6 TABLET in 1 BLISTER PACK", "package_ndc": "68016-301-24", "marketing_end_date": "20261130", "marketing_start_date": "20191206"}], "brand_name": "Anti-diarrheal", "product_id": "68016-301_f05ff0cc-d7bd-45a9-8612-f20870c9668c", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "68016-301", "generic_name": "Loperamide HCl", "labeler_name": "Chain Drug Consortium", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA076497", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20191206"}