Risedronate Sodium

Product NDC
0093-7771
11-digit product format
000937771
Labeler code
0093
Product ID
0093-7771_56853f43-4961-40ff-a5e8-d99b505380a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079215
Marketing category
ANDA
Marketing start
2016-11-28
Marketing end
0000-00-00
Substance
RISEDRONATE SODIUM MONOHYDRATE
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7771-13EA - Each0093-77719e8858e3-3bd0-4d37-829e-6ecedf1f9ae312016-12-07
0093-7771-19EA - Each0093-7771c15bd869-927c-4e2d-ab9c-95039d81372812016-12-07
0093-7771-79EA - Each0093-77719bb3654b-0257-4308-84e5-178eec98547e12016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7771-13000937771133 BLISTER PACK in 1 CARTON (0093-7771-13) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) 3 blister pack2016-11-280000-00-00NoNoCurrent
0093-7771-79000937771791 BLISTER PACK in 1 CARTON (0093-7771-79) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-7771-19) 1 blister pack2016-12-120000-00-00NoNoCurrent