Telmisartan and Amlodipine

Product NDC
42291-794
11-digit product format
422910794
Labeler code
42291
Product ID
42291-794_d5c9e15b-7e82-d9a5-e053-2995a90a9725
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan and Amlodipine
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA201586
Marketing category
ANDA
Marketing start
2017-08-09
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; TELMISARTAN
Active strength
10 mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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
42291-794-30EA - Each42291-7946dc2f6ff-0cb8-4425-84f0-db4f8ec1626d12017-09-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-794-304229107943030 TABLET in 1 BOTTLE (42291-794-30) 30 tablet2017-08-090000-00-00NoNoCurrent