N/A

Product NDC
43386-405
11-digit product format
433860405
Labeler code
43386
Product ID
43386-405_d4f091b9-c66e-6e5f-e053-2a95a90a61f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nitazoxanide
Dosage form
TABLET
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
NDA021497
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2021-02-17
Marketing end
0000-00-00
Substance
NITAZOXANIDE
Active strength
500 mg/1
Pharmacologic classes
Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-405-03EA - Each43386-4059571ce62-4303-45a1-b8a2-2732bbab8be912021-03-02
43386-405-12EA - Each43386-4052d2065aa-7df6-430e-b1d0-171d767c420212021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43386-405-034338604050330 BOTTLE, PLASTIC in 1 CARTON (43386-405-03) > 30 TABLET in 1 BOTTLE, PLASTIC2021-02-170000-00-00NoNoCurrent
43386-405-124338604051212 BOTTLE, PLASTIC in 1 CARTON (43386-405-12) > 12 TABLET in 1 BOTTLE, PLASTIC2021-02-170000-00-00NoNoCurrent