amantadine hydrochloride

Generic: amantadine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amantadine hydrochloride
Generic Name amantadine hydrochloride
Labeler major pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

amantadine hydrochloride 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7042
Product ID 0904-7042_e997ef48-cfa3-4aa8-bbea-be54c4c00f64
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209171
Listing Expiration 2027-12-31
Marketing Start 2017-06-12

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 09047042
Hyphenated Format 0904-7042

Supplemental Identifiers

RxCUI
849389
UNII
M6Q1EO9TD0

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 amantadine hydrochloride (source: ndc)
Generic Name amantadine hydrochloride (source: ndc)
Application Number ANDA209171 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK
  • 500 CAPSULE in 1 BOTTLE (0904-7042-40)
  • 100 CAPSULE in 1 BOTTLE (0904-7042-59)
  • 100 BLISTER PACK in 1 CARTON (0904-7042-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (4)

0904-7042-06 50 BLISTER PACK in 1 CARTON (0904-7042-06) / 1 CAPSULE in 1 BLISTER PACK 0904-7042-40 500 CAPSULE in 1 BOTTLE (0904-7042-40) 0904-7042-59 100 CAPSULE in 1 BOTTLE (0904-7042-59) 0904-7042-61 100 BLISTER PACK in 1 CARTON (0904-7042-61) / 1 CAPSULE in 1 BLISTER PACK

Ingredients (1)

amantadine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Amantadine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e997ef48-cfa3-4aa8-bbea-be54c4c00f64", "openfda": {"unii": ["M6Q1EO9TD0"], "rxcui": ["849389"], "spl_set_id": ["b2f7da34-ad78-4db3-9af1-bdd341e09f16"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7042-06)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7042-06", "marketing_start_date": "20170612"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (0904-7042-40)", "package_ndc": "0904-7042-40", "marketing_start_date": "20170612"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0904-7042-59)", "package_ndc": "0904-7042-59", "marketing_start_date": "20170612"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7042-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7042-61", "marketing_start_date": "20170612"}], "brand_name": "Amantadine Hydrochloride", "product_id": "0904-7042_e997ef48-cfa3-4aa8-bbea-be54c4c00f64", "dosage_form": "CAPSULE", "pharm_class": ["Influenza A M2 Protein Inhibitor [EPC]", "M2 Protein Inhibitors [MoA]"], "product_ndc": "0904-7042", "generic_name": "Amantadine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amantadine Hydrochloride", "active_ingredients": [{"name": "AMANTADINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA209171", "marketing_category": "ANDA", "marketing_start_date": "20170612", "listing_expiration_date": "20271231"}