famotidine

Generic: famotidine

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler alembic pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-293
Product ID 46708-293_02d57009-ba37-4b5d-af59-7a62f1d9e29c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078916
Listing Expiration 2027-12-31
Marketing Start 2016-01-29

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 46708293
Hyphenated Format 46708-293

Supplemental Identifiers

RxCUI
284245 310273
UPC
0346708294304 0346708293307
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 ANDA078916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 CARTON (46708-293-10)
  • 30 TABLET in 1 BOTTLE (46708-293-30)
  • 100 TABLET in 1 BOTTLE (46708-293-31)
  • 500 TABLET in 1 BOTTLE (46708-293-71)
  • 1000 TABLET in 1 BOTTLE (46708-293-91)
source: ndc

Packages (5)

46708-293-10 100 TABLET in 1 CARTON (46708-293-10) 46708-293-30 30 TABLET in 1 BOTTLE (46708-293-30) 46708-293-31 100 TABLET in 1 BOTTLE (46708-293-31) 46708-293-71 500 TABLET in 1 BOTTLE (46708-293-71) 46708-293-91 1000 TABLET in 1 BOTTLE (46708-293-91)

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": "02d57009-ba37-4b5d-af59-7a62f1d9e29c", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0346708294304", "0346708293307"], "unii": ["5QZO15J2Z8"], "rxcui": ["284245", "310273"], "spl_set_id": ["7c0f3fa5-0a44-4a98-bc43-8bff8e95c462"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 CARTON (46708-293-10)", "package_ndc": "46708-293-10", "marketing_start_date": "20160129"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (46708-293-30)", "package_ndc": "46708-293-30", "marketing_start_date": "20160129"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (46708-293-31)", "package_ndc": "46708-293-31", "marketing_start_date": "20160129"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (46708-293-71)", "package_ndc": "46708-293-71", "marketing_start_date": "20160129"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (46708-293-91)", "package_ndc": "46708-293-91", "marketing_start_date": "20160129"}], "brand_name": "Famotidine", "product_id": "46708-293_02d57009-ba37-4b5d-af59-7a62f1d9e29c", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "46708-293", "generic_name": "Famotidine", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA078916", "marketing_category": "ANDA", "marketing_start_date": "20160129", "listing_expiration_date": "20271231"}