PRAZIQUANTEL

Product NDC
49884-231
11-digit product format
498840231
Labeler code
49884
Product ID
49884-231_16be47d2-4bd1-4410-a633-476cdbbbceec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PRAZIQUANTEL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA208820
Marketing category
ANDA
Marketing start
2017-11-27
Substance
PRAZIQUANTEL
Active strength
600 mg/1
Pharmacologic classes
Anthelmintic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRAZIQUANTEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAZIQUANTEL600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6490C9U457
Rxcui198140

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8cabd598-669e-43ab-9753-4aec00a484cbProduct name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-231-83PRAZIQUANTEL6 in 1 BOTTLETABLET, FILM COATED614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-231-83EA - Each49884-2315792c969-6044-4f46-aa9c-3f3633a312be12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-231PRAZIQUANTEL TABLET, FILM COATED [ENDO USA, INC.]14Current NDC, Legacy NDC, 1 package rows20240926_16f2b9c4-a260-4a31-bd52-e5945913246c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198140praziquantel 600 MG Oral TabletPSN16f2b9c4-a260-4a31-bd52-e5945913246c14
198140praziquantel 600 MG Oral TabletSCD16f2b9c4-a260-4a31-bd52-e5945913246c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-231-83498840231836 TABLET, FILM COATED in 1 BOTTLE (49884-231-83) 2017-11-270000-00-00NoNoCurrent