famotidine

Generic: famotidine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

famotidine 40 mg/5mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-775
Product ID 67877-775_87b513db-989d-4c31-b597-1af0093d0085
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216400
Listing Expiration 2026-12-31
Marketing Start 2023-08-24

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 67877775
Hyphenated Format 67877-775

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 ANDA216400 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (67877-775-89)
source: ndc

Packages (1)

67877-775-89 50 mL in 1 BOTTLE (67877-775-89)

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": "87b513db-989d-4c31-b597-1af0093d0085", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310274"], "spl_set_id": ["b2228be0-472b-4e47-9910-af0bf12fde77"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BOTTLE (67877-775-89)", "package_ndc": "67877-775-89", "marketing_start_date": "20230824"}], "brand_name": "Famotidine", "product_id": "67877-775_87b513db-989d-4c31-b597-1af0093d0085", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "67877-775", "generic_name": "Famotidine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "40 mg/5mL"}], "application_number": "ANDA216400", "marketing_category": "ANDA", "marketing_start_date": "20230824", "listing_expiration_date": "20261231"}