nizatidine

Generic: nizatidine

Labeler: epic pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nizatidine
Generic Name nizatidine
Labeler epic pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nizatidine 300 mg/1

Manufacturer
Epic Pharma, LLC

Identifiers & Regulatory

Product NDC 42806-300
Product ID 42806-300_e9957997-8b85-48a0-9bb3-b878cb223236
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076178
Listing Expiration 2026-12-31
Marketing Start 2024-10-25

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 42806300
Hyphenated Format 42806-300

Supplemental Identifiers

RxCUI
198041 312025
UPC
0342806299609 0342806300305
UNII
P41PML4GHR
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 nizatidine (source: ndc)
Generic Name nizatidine (source: ndc)
Application Number ANDA076178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (42806-300-30)
  • 60 CAPSULE in 1 BOTTLE (42806-300-60)
source: ndc

Packages (2)

42806-300-30 30 CAPSULE in 1 BOTTLE (42806-300-30) 42806-300-60 60 CAPSULE in 1 BOTTLE (42806-300-60)

Ingredients (1)

nizatidine (300 mg/1)

Linked Drug Pages (1)

Nizatidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e9957997-8b85-48a0-9bb3-b878cb223236", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0342806299609", "0342806300305"], "unii": ["P41PML4GHR"], "rxcui": ["198041", "312025"], "spl_set_id": ["e9957997-8b85-48a0-9bb3-b878cb223236"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Epic Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (42806-300-30)", "package_ndc": "42806-300-30", "marketing_start_date": "20241025"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (42806-300-60)", "package_ndc": "42806-300-60", "marketing_start_date": "20241025"}], "brand_name": "Nizatidine", "product_id": "42806-300_e9957997-8b85-48a0-9bb3-b878cb223236", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "42806-300", "generic_name": "Nizatidine", "labeler_name": "Epic Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nizatidine", "active_ingredients": [{"name": "NIZATIDINE", "strength": "300 mg/1"}], "application_number": "ANDA076178", "marketing_category": "ANDA", "marketing_start_date": "20241025", "listing_expiration_date": "20261231"}