famotidine

Generic: famotidine

Labeler: navinta llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler navinta llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

famotidine 40 mg/5mL

Manufacturer
Navinta LLC

Identifiers & Regulatory

Product NDC 68475-400
Product ID 68475-400_12419fdc-7a4c-4762-806c-0d56b478ef9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091020
Listing Expiration 2026-12-31
Marketing Start 2021-04-22

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 68475400
Hyphenated Format 68475-400

Supplemental Identifiers

RxCUI
310274
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 ANDA091020 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE, PLASTIC (68475-400-01)
source: ndc

Packages (1)

68475-400-01 50 mL in 1 BOTTLE, PLASTIC (68475-400-01)

Ingredients (1)

famotidine (40 mg/5mL)

Linked Drug Pages (1)

famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "12419fdc-7a4c-4762-806c-0d56b478ef9d", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310274"], "spl_set_id": ["0f34a3be-7554-4040-b808-5ba8bf064abc"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE, PLASTIC (68475-400-01)", "package_ndc": "68475-400-01", "marketing_start_date": "20210422"}], "brand_name": "famotidine", "product_id": "68475-400_12419fdc-7a4c-4762-806c-0d56b478ef9d", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "68475-400", "generic_name": "famotidine", "labeler_name": "Navinta LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/5mL"}], "application_number": "ANDA091020", "marketing_category": "ANDA", "marketing_start_date": "20210422", "listing_expiration_date": "20261231"}