Irbesartan

Product NDC
70518-2211
11-digit product format
705182211
Labeler code
70518
Product ID
70518-2211_dafa2bf6-6f96-c18c-e053-2a95a90a7bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202254
Marketing category
ANDA
Marketing start
2019-07-14
Marketing end
0000-00-00
Substance
IRBESARTAN
Active strength
300 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2211-07051822110090 TABLET in 1 BOTTLE, PLASTIC (70518-2211-0) 90 tablet2019-07-140000-00-00NoNoCurrent