FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
43598-103
11-digit product format
435980103
Labeler code
43598
Product ID
43598-103_d4e74ed4-46a8-d079-8e3e-299f10d739cd
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
2024-04-01
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii48A5M73Z4Q
Rxcui259255, 617310, 617311, 617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
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
43598-103-05Atorvastatin Calcium500 in 1 BOTTLETABLET5004
43598-103-10Atorvastatin Calcium10 in 1 BLISTER PACKTABLET104
43598-103-81Atorvastatin Calcium3 in 1 CARTONTABLET34
43598-103-90Atorvastatin Calcium90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-103-05EA - Each43598-103ea9eb49d-31db-46a4-9fa1-a8c0767b07c412024-09-09
43598-103-90EA - Each43598-103d2515926-79d2-4329-9ed0-038ca3d3280612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-103ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES INC]4Current NDC, 4 package rows20240612_aaf960d1-8bf9-64c6-1e70-8aa33b0ce549.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617310atorvastatin calcium 20 MG Oral TabletPSNaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617311atorvastatin calcium 40 MG Oral TabletPSNaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
259255atorvastatin calcium 80 MG Oral TabletPSNaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617312atorvastatin 10 MG Oral TabletSCDaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617310atorvastatin 20 MG Oral TabletSCDaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617311atorvastatin 40 MG Oral TabletSCDaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
259255atorvastatin 80 MG Oral TabletSCDaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYaaf960d1-8bf9-64c6-1e70-8aa33b0ce5494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-103-0543598010305500 TABLET in 1 BOTTLE (43598-103-05) 500 tablet2024-04-01NoNoHistorical
43598-103-104359801031010 in 1 BLISTER PACKHistorical
43598-103-81435980103813 BLISTER PACK in 1 CARTON (43598-103-81) / 10 TABLET in 1 BLISTER PACK (43598-103-10) 3 blister pack2024-04-01NoNoHistorical
43598-103-904359801039090 TABLET in 1 BOTTLE (43598-103-90) 90 tablet2024-04-01NoNoHistorical