berkley and jensen anti diarrheal

Generic: loperamide hydrochloride

Labeler: bjwc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name berkley and jensen anti diarrheal
Generic Name loperamide hydrochloride
Labeler bjwc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
BJWC

Identifiers & Regulatory

Product NDC 68391-224
Product ID 68391-224_b07567e4-fd50-4071-b5c7-79b02aab0ea5
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075232
Listing Expiration 2026-12-31
Marketing Start 2003-04-19

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391224
Hyphenated Format 68391-224

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 berkley and jensen 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
  • 24 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

68391-224-62 24 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

berkley and jensen anti diarrheal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b07567e4-fd50-4071-b5c7-79b02aab0ea5", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978010"], "spl_set_id": ["dc29a8e9-f916-49d2-b9a6-d2b4537d7b58"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BLISTER PACK in 1 CARTON (68391-224-62)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68391-224-62", "marketing_start_date": "20200115"}], "brand_name": "berkley and jensen anti diarrheal", "product_id": "68391-224_b07567e4-fd50-4071-b5c7-79b02aab0ea5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "68391-224", "generic_name": "Loperamide Hydrochloride", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen anti diarrheal", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA075232", "marketing_category": "ANDA", "marketing_start_date": "20030419", "listing_expiration_date": "20261231"}