PROPRANOLOL HYDROCHLORIDE

Product NDC
68382-161
11-digit product format
683820161
Labeler code
68382
Product ID
68382-161_60266847-3378-4bb7-9b45-1f6917e5b965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA090321
Marketing category
ANDA
Marketing start
2014-04-15
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic 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
68382-161-0168382016101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-161-01) 2014-04-150000-00-00NoNoCurrent
68382-161-0568382016105500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-161-05) 2014-04-150000-00-00NoNoCurrent
68382-161-10683820161101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-161-10) 2014-04-150000-00-00NoNoCurrent
68382-161-166838201611690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-161-16) 2014-04-150000-00-00NoNoCurrent
68382-161-7768382016177100 BLISTER PACK in 1 CARTON (68382-161-77) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-161-30) 100 blister pack2014-04-150000-00-00NoNoCurrent