Irbesartan and Hydrochlorothiazide

Product NDC
70518-2013
11-digit product format
705182013
Labeler code
70518
Product ID
70518-2013_c5d39391-d504-a73e-e053-2a95a90a7cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090351
Marketing category
ANDA
Marketing start
2019-04-12
Marketing end
0000-00-00
Substance
IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength
150 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
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2013-02023-03-07C16284748780-1f386c649-bc92-0266-e053-dadaa90a7c1a3233569a-23c6-469e-8d13-5af9ca38e310
70518-2013-02023-01-30C16284748780-1f386c649-bc92-0266-e053-dadaa90a7c1a3233569a-23c6-469e-8d13-5af9ca38e310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2013-07051820130090 TABLET in 1 BOTTLE, PLASTIC (70518-2013-0) 90 tablet2019-04-120000-00-00NoNoCurrent