famotidine

Generic: famotidine

Labeler: dr.reddys laboratories limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler dr.reddys laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Dr.Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-396
Product ID 55111-396_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077367
Listing Expiration 2026-12-31
Marketing Start 2006-09-30

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 55111396
Hyphenated Format 55111-396

Supplemental Identifiers

RxCUI
199047 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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA077367 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55111-396-01) / 100 TABLET in 1 BOTTLE
  • 1 BLISTER PACK in 1 CARTON (55111-396-08) / 8 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (55111-396-13) / 130 TABLET in 1 BOTTLE
  • 5 BLISTER PACK in 1 CARTON (55111-396-16) / 5 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (55111-396-32) / 170 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-396-35) / 25 TABLET in 1 BOTTLE
  • 2 BOTTLE in 1 CARTON (55111-396-44) / 100 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-396-50) / 50 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-396-65) / 65 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-396-90) / 90 TABLET in 1 BOTTLE
source: ndc

Packages (10)

55111-396-01 1 BOTTLE in 1 CARTON (55111-396-01) / 100 TABLET in 1 BOTTLE 55111-396-08 1 BLISTER PACK in 1 CARTON (55111-396-08) / 8 TABLET in 1 BLISTER PACK 55111-396-13 1 BOTTLE in 1 CARTON (55111-396-13) / 130 TABLET in 1 BOTTLE 55111-396-16 5 BLISTER PACK in 1 CARTON (55111-396-16) / 5 TABLET in 1 BLISTER PACK 55111-396-32 1 BOTTLE in 1 CARTON (55111-396-32) / 170 TABLET in 1 BOTTLE 55111-396-35 1 BOTTLE in 1 CARTON (55111-396-35) / 25 TABLET in 1 BOTTLE 55111-396-44 2 BOTTLE in 1 CARTON (55111-396-44) / 100 TABLET in 1 BOTTLE 55111-396-50 1 BOTTLE in 1 CARTON (55111-396-50) / 50 TABLET in 1 BOTTLE 55111-396-65 1 BOTTLE in 1 CARTON (55111-396-65) / 65 TABLET in 1 BOTTLE 55111-396-90 1 BOTTLE in 1 CARTON (55111-396-90) / 90 TABLET in 1 BOTTLE

Ingredients (1)

famotidine (20 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": "e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["387088a6-8eaa-fc49-8050-a546d0f0fd32"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Dr.Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "55111-396-01", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (55111-396-08)  / 8 TABLET in 1 BLISTER PACK", "package_ndc": "55111-396-08", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-13)  / 130 TABLET in 1 BOTTLE", "package_ndc": "55111-396-13", "marketing_start_date": "20201001"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (55111-396-16)  / 5 TABLET in 1 BLISTER PACK", "package_ndc": "55111-396-16", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-32)  / 170 TABLET in 1 BOTTLE", "package_ndc": "55111-396-32", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-35)  / 25 TABLET in 1 BOTTLE", "package_ndc": "55111-396-35", "marketing_start_date": "20060930"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (55111-396-44)  / 100 TABLET in 1 BOTTLE", "package_ndc": "55111-396-44", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-50)  / 50 TABLET in 1 BOTTLE", "package_ndc": "55111-396-50", "marketing_start_date": "20060930"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-65)  / 65 TABLET in 1 BOTTLE", "package_ndc": "55111-396-65", "marketing_start_date": "20201001"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-396-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "55111-396-90", "marketing_start_date": "20211007"}], "brand_name": "Famotidine", "product_id": "55111-396_e818465f-a1ca-0e6a-f18c-cf2cb2a2cc82", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "55111-396", "generic_name": "Famotidine", "labeler_name": "Dr.Reddys Laboratories Limited", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA077367", "marketing_category": "ANDA", "marketing_start_date": "20060930", "listing_expiration_date": "20261231"}