rimantadine hydrochloride

Generic: rimantadine hydrochloride

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

Drug Facts

Product Profile

Brand Name rimantadine hydrochloride
Generic Name rimantadine hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rimantadine hydrochloride 100 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1911
Product ID 0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076132
Listing Expiration 2026-12-31
Marketing Start 2021-11-16

Pharmacologic Class

Classes
influenza a m2 protein inhibitor [epc] m2 protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151911
Hyphenated Format 0115-1911

Supplemental Identifiers

RxCUI
856605
UNII
JEI07OOS8Y

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 rimantadine hydrochloride (source: ndc)
Generic Name rimantadine hydrochloride (source: ndc)
Application Number ANDA076132 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)
source: ndc

Packages (2)

0115-1911-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01) 0115-1911-02 500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)

Ingredients (1)

rimantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Rimantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f", "openfda": {"unii": ["JEI07OOS8Y"], "rxcui": ["856605"], "spl_set_id": ["49f7d69a-820b-4c75-a31d-b2104c019c12"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0115-1911-01)", "package_ndc": "0115-1911-01", "marketing_start_date": "20211116"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (0115-1911-02)", "package_ndc": "0115-1911-02", "marketing_start_date": "20211116"}], "brand_name": "Rimantadine Hydrochloride", "product_id": "0115-1911_b5f5cd6c-3874-4507-bbd4-72e8c5bfe17f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0115-1911", "generic_name": "Rimantadine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rimantadine Hydrochloride", "active_ingredients": [{"name": "RIMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA076132", "marketing_category": "ANDA", "marketing_start_date": "20211116", "listing_expiration_date": "20261231"}