berkley and jensen famotidine (68391-300)

Drug Facts

Product Profile

Brand Name berkley and jensen famotidine

Generic Name famotidine

Labeler bjwc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

famotidine 20 mg/1

Manufacturer

BJWC

Identifiers & Regulatory

Product NDC 68391-300

Product ID 68391-300_8459c675-5144-445c-afdb-c09b445fc14b

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA077351

Listing Expiration 2027-12-31

Marketing Start 2013-12-09

Pharmacologic Class

Established (EPC)

histamine-2 receptor antagonist [epc]

Mechanism of Action

histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68391300

Hyphenated Format 68391-300

Supplemental Identifiers

RxCUI

310273

UNII

5QZO15J2Z8

NUI

N0000000151 N0000175784

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 famotidine (source: ndc)

Generic Name famotidine (source: ndc)

Application Number ANDA077351 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1

source: ndc

Packaging

2 BOTTLE in 1 PACKAGE (68391-300-82) / 100 TABLET, FILM COATED in 1 BOTTLE
2 BOTTLE in 1 PACKAGE (68391-300-85) / 125 TABLET, FILM COATED in 1 BOTTLE (68391-300-05)

source: ndc

Packages (2)

68391-300-82 2 BOTTLE in 1 PACKAGE (68391-300-82) / 100 TABLET, FILM COATED in 1 BOTTLE 68391-300-85 2 BOTTLE in 1 PACKAGE (68391-300-85) / 125 TABLET, FILM COATED in 1 BOTTLE (68391-300-05)

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

berkley and jensen famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "8459c675-5144-445c-afdb-c09b445fc14b", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["93c857e4-72b3-433e-ae6f-281cd57e3996"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["BJWC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE in 1 PACKAGE (68391-300-82)  / 100 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "68391-300-82", "marketing_start_date": "20131209"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (68391-300-85)  / 125 TABLET, FILM COATED in 1 BOTTLE (68391-300-05)", "package_ndc": "68391-300-85", "marketing_start_date": "20250904"}], "brand_name": "berkley and jensen famotidine", "product_id": "68391-300_8459c675-5144-445c-afdb-c09b445fc14b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68391-300", "generic_name": "Famotidine", "labeler_name": "BJWC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "berkley and jensen famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA077351", "marketing_category": "ANDA", "marketing_start_date": "20131209", "listing_expiration_date": "20271231"}