biltricide

Generic: praziquantel

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name biltricide
Generic Name praziquantel
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

praziquantel 600 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-747
Product ID 50419-747_c9ab40f0-8a11-486f-be88-765af55b6484
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018714
Listing Expiration 2027-12-31
Marketing Start 2011-04-21

Pharmacologic Class

Established (EPC)
anthelmintic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419747
Hyphenated Format 50419-747

Supplemental Identifiers

RxCUI
198140 208975
UNII
6490C9U457
NUI
N0000175481

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 biltricide (source: ndc)
Generic Name praziquantel (source: ndc)
Application Number NDA018714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)
source: ndc

Packages (1)

50419-747-01 6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)

Ingredients (1)

praziquantel (600 mg/1)

Linked Drug Pages (1)

Biltricide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c9ab40f0-8a11-486f-be88-765af55b6484", "openfda": {"nui": ["N0000175481"], "unii": ["6490C9U457"], "rxcui": ["198140", "208975"], "spl_set_id": ["34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9"], "pharm_class_epc": ["Anthelmintic [EPC]"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (50419-747-01)", "package_ndc": "50419-747-01", "marketing_start_date": "20110421"}], "brand_name": "Biltricide", "product_id": "50419-747_c9ab40f0-8a11-486f-be88-765af55b6484", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anthelmintic [EPC]"], "product_ndc": "50419-747", "generic_name": "praziquantel", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Biltricide", "active_ingredients": [{"name": "PRAZIQUANTEL", "strength": "600 mg/1"}], "application_number": "NDA018714", "marketing_category": "NDA", "marketing_start_date": "20110421", "listing_expiration_date": "20271231"}