FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
71610-633
11-digit product format
716100633
Labeler code
71610
Product ID
71610-633_24733c5a-94ea-400b-8e16-62cf696802b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2021-08-01
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
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 PROPYLENE GLYCOL SOLVATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYRZ789OWMI
Rxcui259255

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
71610-633-15ATORVASTATIN CALCIUM15 in 1 BOTTLETABLET, FILM COATED151
71610-633-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
71610-633-45ATORVASTATIN CALCIUM45 in 1 BOTTLETABLET, FILM COATED451
71610-633-60ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-633-15EA - Each71610-633193de51f-9344-4d66-b83c-c3d66c0740b812022-04-06
71610-633-30EA - Each71610-6330a00c179-ae74-46d6-b880-33d6e2c759b612022-04-06
71610-633-45EA - Each71610-6336921f9ec-4af1-4d03-8768-decb3bdbe7da12022-04-06
71610-633-60EA - Each71610-633a99c54e4-9c82-4796-9676-bec8b2ad24b712022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-633ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20220304_2b7fbe2a-1f7a-4944-b589-87ca05af7481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN2b7fbe2a-1f7a-4944-b589-87ca05af74811
259255atorvastatin 80 MG Oral TabletSCD2b7fbe2a-1f7a-4944-b589-87ca05af74811
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY2b7fbe2a-1f7a-4944-b589-87ca05af74811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-633-157161006331515 TABLET, FILM COATED in 1 BOTTLE (71610-633-15) 2022-02-070000-00-00NoNoCurrent
71610-633-307161006333030 TABLET, FILM COATED in 1 BOTTLE (71610-633-30) 2022-02-070000-00-00NoNoCurrent
71610-633-457161006334545 TABLET, FILM COATED in 1 BOTTLE (71610-633-45) 2022-02-070000-00-00NoNoCurrent
71610-633-607161006336090 TABLET, FILM COATED in 1 BOTTLE (71610-633-60) 2022-02-070000-00-00NoNoCurrent