atorvastatin calcium

Product NDC
68382-251
11-digit product format
683820251
Labeler code
68382
Product ID
68382-251_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
40 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
68382-251-10EA - Each68382-25156f70ba7-252d-4a64-98a0-ff46b6bbc9d412018-12-13
68382-251-16EA - Each68382-251df622e6e-51b5-42af-880e-72be74ca376812018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-251ATORVASTATIN 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
68382-251-0168382025101100 TABLET in 1 BOTTLE (68382-251-01) 100 tablet2018-11-210000-00-00NoNoCurrent
68382-251-0568382025105500 TABLET in 1 BOTTLE (68382-251-05) 500 tablet2018-11-210000-00-00NoNoCurrent
68382-251-066838202510630 TABLET in 1 BOTTLE (68382-251-06) 30 tablet2018-11-210000-00-00NoNoCurrent
68382-251-10683820251101000 TABLET in 1 BOTTLE (68382-251-10) 1000 tablet2018-11-210000-00-00NoNoCurrent
68382-251-166838202511690 TABLET in 1 BOTTLE (68382-251-16) 90 tablet2018-11-210000-00-00NoNoCurrent
68382-251-776838202517710 BLISTER PACK in 1 CARTON (68382-251-77) > 10 TABLET in 1 BLISTER PACK (68382-251-30) 10 blister pack2018-11-210000-00-00NoNoCurrent