FDA.reportPublic FDA data

Atorvastatin calcium

Product NDC
72205-025
11-digit product format
722050025
Labeler code
72205
Product ID
72205-025_11823aa6-547f-4c0b-983a-65b837f94e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-025-05Atorvastatin calcium500 in 1 BOTTLETABLET, FILM COATED5007
72205-025-30Atorvastatin calcium30 in 1 BOTTLETABLET, FILM COATED307
72205-025-90Atorvastatin calcium90 in 1 BOTTLETABLET, FILM COATED907
72205-025-99Atorvastatin calcium1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-025-05EA - Each72205-0254d239842-9292-44be-9a91-ea30d7e357c812019-06-19
72205-025-90EA - Each72205-0250abf82bd-29f9-4929-a79e-24e376fa497f12019-06-19
72205-025-99EA - Each72205-025b0e49e83-be03-4fea-bee7-e03523a51b3112021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-025ATORVASTATIN CALCIUM TABLET, FILM COATED [NOVADOZ PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 4 package rows20240614_bc448f40-421c-490f-8c39-fa8135507973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN51e24220-3374-4e5e-9a8d-4113002c5bed8
259255atorvastatin 80 MG Oral TabletSCD51e24220-3374-4e5e-9a8d-4113002c5bed8
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY51e24220-3374-4e5e-9a8d-4113002c5bed8
617312atorvastatin calcium 10 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin calcium 20 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin calcium 40 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin calcium 80 MG Oral TabletPSNbc448f40-421c-490f-8c39-fa81355079737
617312atorvastatin 10 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin 20 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin 40 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin 80 MG Oral TabletSCDbc448f40-421c-490f-8c39-fa81355079737
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYbc448f40-421c-490f-8c39-fa81355079737
259255atorvastatin calcium 80 MG Oral TabletPSN00afce9b-48c9-487a-a738-e359c005c7076
259255atorvastatin 80 MG Oral TabletSCD00afce9b-48c9-487a-a738-e359c005c7076
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY00afce9b-48c9-487a-a738-e359c005c7076
259255atorvastatin calcium 80 MG Oral TabletPSN01eadde8-37f3-4474-995f-22c1a65adf125
259255atorvastatin 80 MG Oral TabletSCD01eadde8-37f3-4474-995f-22c1a65adf125
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY01eadde8-37f3-4474-995f-22c1a65adf125
259255atorvastatin calcium 80 MG Oral TabletPSN9168df23-4260-46be-9556-8b037af0ea284
259255atorvastatin calcium 80 MG Oral TabletPSN498ef8e6-3366-42f4-99fe-b3e1dedae8874
259255atorvastatin 80 MG Oral TabletSCD9168df23-4260-46be-9556-8b037af0ea284
259255atorvastatin 80 MG Oral TabletSCD498ef8e6-3366-42f4-99fe-b3e1dedae8874
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY9168df23-4260-46be-9556-8b037af0ea284
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY498ef8e6-3366-42f4-99fe-b3e1dedae8874
259255atorvastatin calcium 80 MG Oral TabletPSN8d5b85cf-d8a0-e4d7-e053-2a95a90aad673
259255atorvastatin 80 MG Oral TabletSCD8d5b85cf-d8a0-e4d7-e053-2a95a90aad673
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY8d5b85cf-d8a0-e4d7-e053-2a95a90aad673
259255atorvastatin calcium 80 MG Oral TabletPSN124c111c-9272-eca9-e063-6394a90a0ad52
259255atorvastatin 80 MG Oral TabletSCD124c111c-9272-eca9-e063-6394a90a0ad52
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY124c111c-9272-eca9-e063-6394a90a0ad52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72205-025-0572205002505500 TABLET, FILM COATED in 1 BOTTLE (72205-025-05) 2019-02-080000-00-00NoNoCurrent
72205-025-307220500253030 TABLET, FILM COATED in 1 BOTTLE (72205-025-30) 2019-02-080000-00-00NoNoCurrent
72205-025-907220500259090 TABLET, FILM COATED in 1 BOTTLE (72205-025-90) 2019-02-080000-00-00NoNoCurrent
72205-025-99722050025991000 TABLET, FILM COATED in 1 BOTTLE (72205-025-99) 2021-07-190000-00-00NoNoCurrent