praziquantel

Generic: praziquantel

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name praziquantel
Generic Name praziquantel
Labeler endo usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

praziquantel 600 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-231
Product ID 49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208820
Listing Expiration 2026-12-31
Marketing Start 2017-11-27

Pharmacologic Class

Established (EPC)
anthelmintic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884231
Hyphenated Format 49884-231

Supplemental Identifiers

RxCUI
198140
UPC
0349884231835
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 praziquantel (source: ndc)
Generic Name praziquantel (source: ndc)
Application Number ANDA208820 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 600 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83)
source: ndc

Packages (1)

49884-231-83 6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83)

Ingredients (1)

praziquantel (600 mg/1)

Linked Drug Pages (1)

PRAZIQUANTEL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "16be47d2-4bd1-4410-a633-476cdbbbceec", "openfda": {"nui": ["N0000175481"], "upc": ["0349884231835"], "unii": ["6490C9U457"], "rxcui": ["198140"], "spl_set_id": ["16f2b9c4-a260-4a31-bd52-e5945913246c"], "pharm_class_epc": ["Anthelmintic [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (49884-231-83)", "package_ndc": "49884-231-83", "marketing_start_date": "20171127"}], "brand_name": "PRAZIQUANTEL", "product_id": "49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anthelmintic [EPC]"], "product_ndc": "49884-231", "generic_name": "PRAZIQUANTEL", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAZIQUANTEL", "active_ingredients": [{"name": "PRAZIQUANTEL", "strength": "600 mg/1"}], "application_number": "ANDA208820", "marketing_category": "ANDA", "marketing_start_date": "20171127", "listing_expiration_date": "20261231"}