FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
16714-175
11-digit product format
167140175
Labeler code
16714
Product ID
16714-175_22845272-c73e-8982-c2f6-aa09f6c06d3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NORTHSTAR RX LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2021-08-01
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
40 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 PROPYLENE GLYCOL SOLVATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255, 617310, 617311, 617312

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-175-01ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED909
16714-175-02ATORVASTATIN CALCIUM500 in 1 BOTTLETABLET, FILM COATED5009
16714-175-03ATORVASTATIN CALCIUM1000 in 1 BOTTLETABLET, FILM COATED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-175-01EA - Each16714-175a778cd16-ea81-4337-b65b-92570307cd9212021-09-07
16714-175-02EA - Each16714-1751c53791b-7423-49cc-8f6c-9797948fc7cd12021-09-07
16714-175-03EA - Each16714-17561cc791d-ff75-43d1-896d-51c1e8f4884612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-175ATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHSTAR RX LLC]9Current NDC, Legacy NDC, 3 package rows20250411_52d8508b-aa98-cd89-5991-e2b5f982b6c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN52d8508b-aa98-cd89-5991-e2b5f982b6c69
617310atorvastatin calcium 20 MG Oral TabletPSN52d8508b-aa98-cd89-5991-e2b5f982b6c69
617311atorvastatin calcium 40 MG Oral TabletPSN52d8508b-aa98-cd89-5991-e2b5f982b6c69
259255atorvastatin calcium 80 MG Oral TabletPSN52d8508b-aa98-cd89-5991-e2b5f982b6c69
617312atorvastatin 10 MG Oral TabletSCD52d8508b-aa98-cd89-5991-e2b5f982b6c69
617310atorvastatin 20 MG Oral TabletSCD52d8508b-aa98-cd89-5991-e2b5f982b6c69
617311atorvastatin 40 MG Oral TabletSCD52d8508b-aa98-cd89-5991-e2b5f982b6c69
259255atorvastatin 80 MG Oral TabletSCD52d8508b-aa98-cd89-5991-e2b5f982b6c69
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY52d8508b-aa98-cd89-5991-e2b5f982b6c69
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY52d8508b-aa98-cd89-5991-e2b5f982b6c69
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY52d8508b-aa98-cd89-5991-e2b5f982b6c69
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY52d8508b-aa98-cd89-5991-e2b5f982b6c69
617311atorvastatin calcium 40 MG Oral TabletPSN0ab0bcac-10a3-4178-9674-3730683a41832
617311atorvastatin calcium 40 MG Oral TabletPSNd21a92f4-c669-7d19-e053-2a95a90a6d982
617311atorvastatin 40 MG Oral TabletSCD0ab0bcac-10a3-4178-9674-3730683a41832
617311atorvastatin 40 MG Oral TabletSCDd21a92f4-c669-7d19-e053-2a95a90a6d982
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYd21a92f4-c669-7d19-e053-2a95a90a6d982
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY0ab0bcac-10a3-4178-9674-3730683a41832
617311atorvastatin calcium 40 MG Oral TabletPSN1b8c55ef-160d-42df-95d1-c008f1182e3e1
617311atorvastatin 40 MG Oral TabletSCD1b8c55ef-160d-42df-95d1-c008f1182e3e1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1b8c55ef-160d-42df-95d1-c008f1182e3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-175-011671401750190 TABLET, FILM COATED in 1 BOTTLE (16714-175-01) 2021-08-010000-00-00NoNoCurrent
16714-175-0216714017502500 TABLET, FILM COATED in 1 BOTTLE (16714-175-02) 2021-08-010000-00-00NoNoCurrent
16714-175-03167140175031000 TABLET, FILM COATED in 1 BOTTLE (16714-175-03) 2021-08-010000-00-00NoNoCurrent