Atorvastatin Calcium

Product NDC
68788-8315
11-digit product format
687888315
Labeler code
68788
Product ID
68788-8315_a3f35de1-9a72-4cea-a8e4-ab209456d71b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceutical Inc.
Application
ANDA076477
Marketing category
ANDA
Marketing start
2022-12-21
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
68788-8315-1EA - Each68788-8315953ee1ce-ab2e-47d8-954e-c602f33420cb12023-02-06
68788-8315-3EA - Each68788-8315da404448-310c-48e1-b442-87884915912f12023-02-06
68788-8315-6EA - Each68788-8315a4bf66cb-bc13-48cb-b6fb-a46062826c1e12023-02-06
68788-8315-9EA - Each68788-831566454f05-bb21-49c3-ad56-94e05d5f7d8f12023-02-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8315-168788831501100 TABLET, FILM COATED in 1 BOTTLE (68788-8315-1) 2022-12-210000-00-00NoNoCurrent
68788-8315-36878883150330 TABLET, FILM COATED in 1 BOTTLE (68788-8315-3) 2022-12-210000-00-00NoNoCurrent
68788-8315-66878883150660 TABLET, FILM COATED in 1 BOTTLE (68788-8315-6) 2022-12-210000-00-00NoNoCurrent
68788-8315-96878883150990 TABLET, FILM COATED in 1 BOTTLE (68788-8315-9) 2022-12-210000-00-00NoNoCurrent