Telmisartan

Product NDC
0781-5378
11-digit product format
007815378
Labeler code
0781
Product ID
0781-5378_616e4c7d-2752-4514-ba48-d8ba645f6baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Telmisartan
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA203867
Marketing category
ANDA
Marketing start
2015-02-06
Marketing end
0000-00-00
Substance
TELMISARTAN
Active strength
80 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5378-06EA - Each0781-53781550df43-fe77-46dd-9838-91c25a9fd74512015-03-03
0781-5378-64EA - Each0781-53789469c53e-9ea1-41a3-8aa8-c3d494bde8f112015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5378-060078153780610 TABLET in 1 BLISTER PACK (0781-5378-06) 10 tablet2015-02-060000-00-00NoNoCurrent
0781-5378-640078153786430 TABLET in 1 CARTON (0781-5378-64) 30 tablet2015-02-060000-00-00NoNoCurrent