famotidine 10 mg

Generic: famotidine 10 mg

Labeler: marksans pharma limited
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine 10 mg
Generic Name famotidine 10 mg
Labeler marksans pharma limited
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

famotidine 10 mg/1

Manufacturer
MARKSANS PHARMA LIMITED

Identifiers & Regulatory

Product NDC 25000-086
Product ID 25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA217543
Listing Expiration 2026-12-31
Marketing Start 2023-03-10

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 25000086
Hyphenated Format 25000-086

Supplemental Identifiers

RxCUI
199047 310273
UPC
0325000086039 0325000087364 0325000086367 0325000086084 0325000087081 0325000087036 0325000087821
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 10 mg (source: ndc)
Generic Name famotidine 10 mg (source: ndc)
Application Number ANDA217543 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLE
  • 3 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACK
source: ndc

Packages (4)

25000-086-03 1 BOTTLE in 1 CARTON (25000-086-03) / 30 TABLET, COATED in 1 BOTTLE 25000-086-07 1 BOTTLE in 1 CARTON (25000-086-07) / 90 TABLET, COATED in 1 BOTTLE 25000-086-08 1 BOTTLE in 1 CARTON (25000-086-08) / 100 TABLET, COATED in 1 BOTTLE 25000-086-36 3 BLISTER PACK in 1 CARTON (25000-086-36) / 10 TABLET, COATED in 1 BLISTER PACK

Ingredients (1)

famotidine (10 mg/1)

Linked Drug Pages (1)

Famotidine 10 mg, Famotidine 20 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0325000086039", "0325000087364", "0325000086367", "0325000086084", "0325000087081", "0325000087036", "0325000087821"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "310273"], "spl_set_id": ["58b653eb-6539-4b79-9d22-df6eaf35307f"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["MARKSANS PHARMA LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-086-03)  / 30 TABLET, COATED in 1 BOTTLE", "package_ndc": "25000-086-03", "marketing_start_date": "20230310"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-086-07)  / 90 TABLET, COATED in 1 BOTTLE", "package_ndc": "25000-086-07", "marketing_start_date": "20240424"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (25000-086-08)  / 100 TABLET, COATED in 1 BOTTLE", "package_ndc": "25000-086-08", "marketing_start_date": "20230310"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (25000-086-36)  / 10 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "25000-086-36", "marketing_start_date": "20230310"}], "brand_name": "Famotidine 10 mg", "product_id": "25000-086_c1fe0ae2-1d7b-409d-97cb-9e03eeb7f402", "dosage_form": "TABLET, COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "25000-086", "generic_name": "Famotidine 10 mg", "labeler_name": "MARKSANS PHARMA LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine 10 mg", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "ANDA217543", "marketing_category": "ANDA", "marketing_start_date": "20230310", "listing_expiration_date": "20261231"}