Fexofenadine hydrochloride

Product NDC
68071-5191
11-digit product format
680715191
Labeler code
68071
Product ID
68071-5191_d774a86f-537d-4344-e053-2a95a90a81e7
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076502
Marketing category
ANDA
Marketing start
2011-01-03
Marketing end
0000-00-00
Substance
FEXOFENADINE HYDROCHLORIDE
Active strength
180 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5191-32022-02-07C16284748780-1d6a99b39-bbbf-a426-e053-dadaa90af4c2a00eca6b-2d4e-7d32-e053-2995a90aaaaf
68071-5191-32022-01-28C16284748780-1d6a99b39-bbbf-a426-e053-dadaa90af4c2a00eca6b-2d4e-7d32-e053-2995a90aaaaf

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5191-36807151910330 TABLET in 1 BOTTLE (68071-5191-3) 30 tablet2020-03-040000-00-00NoNoCurrent