Atorvastatin Calcium

Product NDC
62175-892
Requested package NDC
62175-892-44
11-digit product format
621750892
Labeler code
62175
Product ID
62175-892_e20ad87d-3bf3-4d7d-a014-70dc5ef98e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA091624
Marketing category
ANDA
Marketing start
2013-04-05
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62175-89262175-892-44DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091624-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05
A091624-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05
A091624-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05
A091624-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A091624-001AB
A091624-002AB
A091624-003AB
A091624-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091624-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091624-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091624-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-004AB1d06236e962d9…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-892-41EA - Each62175-89206940182-e5c4-47b8-9a17-36233986854b12013-05-02
62175-892-46EA - Each62175-892ed40ac0f-f00d-42cf-b6bc-b30baed0c6a112013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERINACTIVE INGREDIENT905HNO1SIHATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]8
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN062f997d-1b21-4657-9dfa-99cb318d4479100
617311atorvastatin 40 MG Oral TabletSCD062f997d-1b21-4657-9dfa-99cb318d4479100
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY062f997d-1b21-4657-9dfa-99cb318d4479100
617312atorvastatin calcium 10 MG Oral TabletPSNe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617310atorvastatin calcium 20 MG Oral TabletPSNe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617311atorvastatin calcium 40 MG Oral TabletPSNe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617312atorvastatin 10 MG Oral TabletSCDe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617310atorvastatin 20 MG Oral TabletSCDe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617311atorvastatin 40 MG Oral TabletSCDe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYe1d39d2f-7c65-4b68-acfa-0d345714ce6e8
617311atorvastatin calcium 40 MG Oral TabletPSN888a969b-95e0-296c-e053-2995a90afa247
617311atorvastatin 40 MG Oral TabletSCD888a969b-95e0-296c-e053-2995a90afa247
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY888a969b-95e0-296c-e053-2995a90afa247
617311atorvastatin calcium 40 MG Oral TabletPSNba63a6f7-e09c-7cae-e053-2995a90a829e1
617311atorvastatin 40 MG Oral TabletSCDba63a6f7-e09c-7cae-e053-2995a90a829e1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYba63a6f7-e09c-7cae-e053-2995a90a829e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-892-44621750892442500 TABLET, FILM COATED in 1 BOTTLE (62175-892-44) 2013-04-050000-00-00NoNoCurrent