atorvastatin calcium

Product NDC
68382-250
11-digit product format
683820250
Labeler code
68382
Product ID
68382-250_5f8a8857-027e-4778-91e6-eb4a7f891652
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206536
Marketing category
ANDA
Marketing start
2018-11-21
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
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
68382-250-10EA - Each68382-25092b55f92-2311-4a71-b86b-fa604a974ffb12018-12-13
68382-250-16EA - Each68382-250eabac6e1-1b13-46ac-a706-0a44556bdd2a12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-250ATORVASTATIN CALCIUM TABLET [ZYDUS PHARMACEUTICALS USA INC.]11Legacy NDC20241023_f99b0839-28dd-4e77-b920-570af6843052.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-250-0168382025001100 TABLET in 1 BOTTLE (68382-250-01) 100 tablet2018-11-210000-00-00NoNoCurrent
68382-250-0568382025005500 TABLET in 1 BOTTLE (68382-250-05) 500 tablet2018-11-210000-00-00NoNoCurrent
68382-250-066838202500630 TABLET in 1 BOTTLE (68382-250-06) 30 tablet2018-11-210000-00-00NoNoCurrent
68382-250-10683820250101000 TABLET in 1 BOTTLE (68382-250-10) 1000 tablet2018-11-210000-00-00NoNoCurrent
68382-250-166838202501690 TABLET in 1 BOTTLE (68382-250-16) 90 tablet2018-11-210000-00-00NoNoCurrent
68382-250-776838202507710 BLISTER PACK in 1 CARTON (68382-250-77) > 10 TABLET in 1 BLISTER PACK (68382-250-30) 10 blister pack2018-11-210000-00-00NoNoCurrent