famotidine

Generic: famotidine

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

famotidine 10 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-753
Product ID 25021-753_11856fb6-3d0b-4db4-889f-083e7f4285be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075622
Listing Expiration 2026-12-31
Marketing Start 2024-12-15

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 25021753
Hyphenated Format 25021-753

Supplemental Identifiers

RxCUI
204441 1743833
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 ANDA075622 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (25021-753-02) / 2 mL in 1 VIAL
source: ndc

Packages (1)

25021-753-02 25 VIAL in 1 CARTON (25021-753-02) / 2 mL in 1 VIAL

Ingredients (1)

famotidine (10 mg/mL)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "11856fb6-3d0b-4db4-889f-083e7f4285be", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["204441", "1743833"], "spl_set_id": ["2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (25021-753-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-753-02", "marketing_start_date": "20241215"}], "brand_name": "Famotidine", "product_id": "25021-753_11856fb6-3d0b-4db4-889f-083e7f4285be", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "25021-753", "generic_name": "Famotidine", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/mL"}], "application_number": "ANDA075622", "marketing_category": "ANDA", "marketing_start_date": "20241215", "listing_expiration_date": "20261231"}