Valsartan and Hydrochlorothiazide

Product NDC
68071-4096
11-digit product format
680714096
Labeler code
68071
Product ID
68071-4096_d5930cc8-00b9-de99-e053-2a95a90ae51b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203145
Marketing category
ANDA
Marketing start
2013-04-19
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
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
68071-4096-32020-10-09C16284748780-19d75b9d0-8d82-f424-e053-dadaa90a57ce592d1cfd-8045-3cd3-e053-2991aa0a88f2
68071-4096-32020-01-31C16284748780-19d75b9d0-8d82-f424-e053-dadaa90a57ce592d1cfd-8045-3cd3-e053-2991aa0a88f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4096-36807140960330 TABLET, FILM COATED in 1 BOTTLE (68071-4096-3) 2017-09-140000-00-00NoNoCurrent