nizatidine

Generic: nizatidine

Labeler: dr reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nizatidine
Generic Name nizatidine
Labeler dr reddy's laboratories limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nizatidine 300 mg/1

Manufacturer
Dr Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-311
Product ID 55111-311_254e5866-1ba8-8d97-bc03-19916119ff87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077314
Listing Expiration 2026-12-31
Marketing Start 2005-09-15

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 55111311
Hyphenated Format 55111-311

Supplemental Identifiers

RxCUI
198041 312025
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 ANDA077314 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (55111-311-01)
  • 500 CAPSULE in 1 BOTTLE (55111-311-05)
  • 30 CAPSULE in 1 BOTTLE (55111-311-30)
  • 60 CAPSULE in 1 BOTTLE (55111-311-60)
  • 10 BLISTER PACK in 1 CARTON (55111-311-78) / 10 CAPSULE in 1 BLISTER PACK (55111-311-79)
source: ndc

Packages (5)

55111-311-01 100 CAPSULE in 1 BOTTLE (55111-311-01) 55111-311-05 500 CAPSULE in 1 BOTTLE (55111-311-05) 55111-311-30 30 CAPSULE in 1 BOTTLE (55111-311-30) 55111-311-60 60 CAPSULE in 1 BOTTLE (55111-311-60) 55111-311-78 10 BLISTER PACK in 1 CARTON (55111-311-78) / 10 CAPSULE in 1 BLISTER PACK (55111-311-79)

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": "254e5866-1ba8-8d97-bc03-19916119ff87", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["P41PML4GHR"], "rxcui": ["198041", "312025"], "spl_set_id": ["faaa7cc4-fda9-d5b8-de2a-71c8744ccb76"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Dr Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (55111-311-01)", "package_ndc": "55111-311-01", "marketing_start_date": "20050915"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (55111-311-05)", "package_ndc": "55111-311-05", "marketing_start_date": "20050915"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (55111-311-30)", "package_ndc": "55111-311-30", "marketing_start_date": "20050915"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (55111-311-60)", "package_ndc": "55111-311-60", "marketing_start_date": "20050915"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-311-78)  / 10 CAPSULE in 1 BLISTER PACK (55111-311-79)", "package_ndc": "55111-311-78", "marketing_start_date": "20050915"}], "brand_name": "Nizatidine", "product_id": "55111-311_254e5866-1ba8-8d97-bc03-19916119ff87", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "55111-311", "generic_name": "Nizatidine", "labeler_name": "Dr Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nizatidine", "active_ingredients": [{"name": "NIZATIDINE", "strength": "300 mg/1"}], "application_number": "ANDA077314", "marketing_category": "ANDA", "marketing_start_date": "20050915", "listing_expiration_date": "20261231"}