FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
43598-830
11-digit product format
435980830
Labeler code
43598
Product ID
43598-830_14581fb9-c75a-8300-dffc-732f7533a1ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA214659
Marketing category
ANDA
Marketing start
2022-08-29
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
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-830-05Atorvastatin Calcium500 in 1 BOTTLETABLET5008
43598-830-78Atorvastatin Calcium10 in 1 CARTONTABLET108
43598-830-79Atorvastatin Calcium10 in 1 BLISTER PACKTABLET108
43598-830-90Atorvastatin Calcium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-830-05EA - Each43598-83056542fcb-accf-4a72-b166-13403f16e15112022-11-07
43598-830-90EA - Each43598-8308b1fcd50-f665-411a-ace5-7273ad26dc5712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-830ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES INC]8Current NDC, Legacy NDC, 4 package rows20240612_652f77a0-2145-896d-c760-e99e87507161.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin calcium 20 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin calcium 40 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin calcium 80 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617312atorvastatin 10 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin 20 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin 40 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin 80 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
617312atorvastatin calcium 10 MG Oral TabletPSN05ccbbce-a3d1-5e44-e063-6394a90a21841
617312atorvastatin 10 MG Oral TabletSCD05ccbbce-a3d1-5e44-e063-6394a90a21841
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY05ccbbce-a3d1-5e44-e063-6394a90a21841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-830-0543598083005500 TABLET in 1 BOTTLE (43598-830-05) 500 tablet2022-08-290000-00-00NoNoCurrent
43598-830-784359808307810 BLISTER PACK in 1 CARTON (43598-830-78) / 10 TABLET in 1 BLISTER PACK (43598-830-79) 10 blister pack2022-08-290000-00-00NoNoCurrent
43598-830-794359808307910 in 1 BLISTER PACKHistorical
43598-830-904359808309090 TABLET in 1 BOTTLE (43598-830-90) 90 tablet2022-08-290000-00-00NoNoCurrent