ranitidine

Generic: ranitidine

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

Drug Facts

Product Profile

Brand Name ranitidine
Generic Name ranitidine
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ranitidine hydrochloride 300 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-254
Product ID 53746-254_8625e9c6-6542-43d2-a657-34161884a7d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077824
Listing Expiration 2026-12-31
Marketing Start 2009-12-16

Pharmacologic Class

Classes
histamine h2 receptor antagonists [moa] histamine-2 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746254
Hyphenated Format 53746-254

Supplemental Identifiers

RxCUI
198191 198193
UPC
0353746254016 0353746253019
UNII
BK76465IHM

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 ranitidine (source: ndc)
Generic Name ranitidine (source: ndc)
Application Number ANDA077824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-254-01)
  • 250 TABLET in 1 BOTTLE (53746-254-02)
  • 30 TABLET in 1 BOTTLE (53746-254-30)
source: ndc

Packages (3)

53746-254-01 100 TABLET in 1 BOTTLE (53746-254-01) 53746-254-02 250 TABLET in 1 BOTTLE (53746-254-02) 53746-254-30 30 TABLET in 1 BOTTLE (53746-254-30)

Ingredients (1)

ranitidine hydrochloride (300 mg/1)

Linked Drug Pages (1)

Ranitidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8625e9c6-6542-43d2-a657-34161884a7d0", "openfda": {"upc": ["0353746254016", "0353746253019"], "unii": ["BK76465IHM"], "rxcui": ["198191", "198193"], "spl_set_id": ["b38a3332-5c54-453f-aeb7-070f830955c2"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-254-01)", "package_ndc": "53746-254-01", "marketing_start_date": "20091216"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (53746-254-02)", "package_ndc": "53746-254-02", "marketing_start_date": "20091216"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-254-30)", "package_ndc": "53746-254-30", "marketing_start_date": "20091216"}], "brand_name": "Ranitidine", "product_id": "53746-254_8625e9c6-6542-43d2-a657-34161884a7d0", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "53746-254", "generic_name": "Ranitidine", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ranitidine", "active_ingredients": [{"name": "RANITIDINE HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA077824", "marketing_category": "ANDA", "marketing_start_date": "20091216", "listing_expiration_date": "20261231"}