famotidine

Generic: famotidine

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler aurohealth llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 10 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-705
Product ID 58602-705_83d5769e-ef9c-4ce5-afd5-a2dd7496274a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206531
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

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 58602705
Hyphenated Format 58602-705

Supplemental Identifiers

RxCUI
199047
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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA206531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (58602-705-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)
  • 4 BLISTER PACK in 1 CARTON (58602-705-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)
  • 1 BOTTLE in 1 CARTON (58602-705-14) / 50 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-19) / 90 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-32) / 180 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-34) / 200 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-39) / 365 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-40) / 500 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-41) / 1000 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-44) / 400 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-84) / 30 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-705-88) / 750 TABLET, FILM COATED in 1 BOTTLE
  • 90 TABLET, FILM COATED in 1 BOTTLE (58602-705-93)
source: ndc

Packages (14)

58602-705-09 3 BLISTER PACK in 1 CARTON (58602-705-09) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 58602-705-12 4 BLISTER PACK in 1 CARTON (58602-705-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03) 58602-705-14 1 BOTTLE in 1 CARTON (58602-705-14) / 50 TABLET, FILM COATED in 1 BOTTLE 58602-705-15 1 BOTTLE in 1 CARTON (58602-705-15) / 60 TABLET, FILM COATED in 1 BOTTLE 58602-705-19 1 BOTTLE in 1 CARTON (58602-705-19) / 90 TABLET, FILM COATED in 1 BOTTLE 58602-705-32 1 BOTTLE in 1 CARTON (58602-705-32) / 180 TABLET, FILM COATED in 1 BOTTLE 58602-705-34 1 BOTTLE in 1 CARTON (58602-705-34) / 200 TABLET, FILM COATED in 1 BOTTLE 58602-705-39 1 BOTTLE in 1 CARTON (58602-705-39) / 365 TABLET, FILM COATED in 1 BOTTLE 58602-705-40 1 BOTTLE in 1 CARTON (58602-705-40) / 500 TABLET, FILM COATED in 1 BOTTLE 58602-705-41 1 BOTTLE in 1 CARTON (58602-705-41) / 1000 TABLET, FILM COATED in 1 BOTTLE 58602-705-44 1 BOTTLE in 1 CARTON (58602-705-44) / 400 TABLET, FILM COATED in 1 BOTTLE 58602-705-84 1 BOTTLE in 1 CARTON (58602-705-84) / 30 TABLET, FILM COATED in 1 BOTTLE 58602-705-88 1 BOTTLE in 1 CARTON (58602-705-88) / 750 TABLET, FILM COATED in 1 BOTTLE 58602-705-93 90 TABLET, FILM COATED in 1 BOTTLE (58602-705-93)

Ingredients (1)

famotidine (10 mg/1)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "83d5769e-ef9c-4ce5-afd5-a2dd7496274a", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047"], "spl_set_id": ["756c7234-6a63-4b1b-be36-2b1ed09e67a0"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-705-09)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)", "package_ndc": "58602-705-09", "marketing_start_date": "20160426"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-705-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (58602-705-03)", "package_ndc": "58602-705-12", "marketing_start_date": "20160426"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-14)  / 50 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-14", "marketing_start_date": "20191221"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-15)  / 60 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-15", "marketing_start_date": "20160426"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-19)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-19", "marketing_start_date": "20160426"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-32)  / 180 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-32", "marketing_start_date": "20220218"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-34)  / 200 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-34", "marketing_start_date": "20200722"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-39)  / 365 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-39", "marketing_start_date": "20200722"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-40)  / 500 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-40", "marketing_start_date": "20200722"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-41)  / 1000 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-41", "marketing_start_date": "20200904"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-44)  / 400 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-44", "marketing_start_date": "20200722"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-84)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-84", "marketing_start_date": "20190513"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-705-88)  / 750 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "58602-705-88", "marketing_start_date": "20200722"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (58602-705-93)", "package_ndc": "58602-705-93", "marketing_start_date": "20160426"}], "brand_name": "Famotidine", "product_id": "58602-705_83d5769e-ef9c-4ce5-afd5-a2dd7496274a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "58602-705", "generic_name": "Famotidine", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA206531", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}