nizatidine

Generic: nizatidine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nizatidine
Generic Name nizatidine
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

nizatidine 15 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 60846-301
Product ID 60846-301_aedc4160-2165-451e-8a3b-26d3bb911242
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090576
Listing Expiration 2026-12-31
Marketing Start 2016-08-12

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 60846301
Hyphenated Format 60846-301

Supplemental Identifiers

RxCUI
476872
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 ANDA090576 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/mL
source: ndc
Packaging
  • 480 mL in 1 BOTTLE (60846-301-15)
source: ndc

Packages (1)

60846-301-15 480 mL in 1 BOTTLE (60846-301-15)

Ingredients (1)

nizatidine (15 mg/mL)

Linked Drug Pages (1)

NIZATIDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aedc4160-2165-451e-8a3b-26d3bb911242", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["P41PML4GHR"], "rxcui": ["476872"], "spl_set_id": ["39e62997-8781-449a-e054-00144ff88e88"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "480 mL in 1 BOTTLE (60846-301-15)", "package_ndc": "60846-301-15", "marketing_start_date": "20160812"}], "brand_name": "NIZATIDINE", "product_id": "60846-301_aedc4160-2165-451e-8a3b-26d3bb911242", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "60846-301", "generic_name": "NIZATIDINE", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NIZATIDINE", "active_ingredients": [{"name": "NIZATIDINE", "strength": "15 mg/mL"}], "application_number": "ANDA090576", "marketing_category": "ANDA", "marketing_start_date": "20160812", "listing_expiration_date": "20261231"}