atorvastatin calcium

Product NDC
68382-249
11-digit product format
683820249
Labeler code
68382
Product ID
68382-249_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
10 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
68382-249-10EA - Each68382-24969d8d07a-cc4c-47c9-bd25-755e18809d3512018-12-13
68382-249-16EA - Each68382-2496d0f6169-eb25-4a8f-aa87-7793b2b7464c12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-249ATORVASTATIN 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
68382-249-0168382024901100 TABLET in 1 BOTTLE (68382-249-01) 100 tablet2018-11-210000-00-00NoNoCurrent
68382-249-0568382024905500 TABLET in 1 BOTTLE (68382-249-05) 500 tablet2018-11-210000-00-00NoNoCurrent
68382-249-066838202490630 TABLET in 1 BOTTLE (68382-249-06) 30 tablet2018-11-210000-00-00NoNoCurrent
68382-249-10683820249101000 TABLET in 1 BOTTLE (68382-249-10) 1000 tablet2018-11-210000-00-00NoNoCurrent
68382-249-166838202491690 TABLET in 1 BOTTLE (68382-249-16) 90 tablet2018-11-210000-00-00NoNoCurrent
68382-249-776838202497710 BLISTER PACK in 1 CARTON (68382-249-77) > 10 TABLET in 1 BLISTER PACK (68382-249-30) 10 blister pack2018-11-210000-00-00NoNoCurrent