Atorvastatin Calcium

Product NDC
43353-959
11-digit product format
433530959
Labeler code
43353
Product ID
43353-959_73131824-586d-4048-879b-a4d3b7cbdf30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077575
Marketing category
ANDA
Marketing start
2012-05-29
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
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-959DDiscontinued by firm2026-10-05
excluded packagepackage43353-95943353-959-15DDiscontinued by firm2026-10-05
excluded packagepackage43353-95943353-959-45DDiscontinued by firm2026-10-05

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-959-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-959-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-959-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-959-15f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077575-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29
A077575-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29
A077575-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29
A077575-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077575-001AB
A077575-002AB
A077575-003AB
A077575-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2984e616aacf4f…
2026-09-14 22:38:342026-08A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2984e616aacf4f…
2026-08-18 06:07:402026-07A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-05-295bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077575-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077575-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077575-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077575-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077575-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077575-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077575-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077575-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077575-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077575-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077575-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077575-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077575-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077575-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077575-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077575-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-959-15EA - Each43353-959cad5975e-b5a0-425b-82ce-ba5af43859b512016-07-19
43353-959-45EA - Each43353-95928f8e1cd-6c18-4719-9314-f3413470a1b012016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-959ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20160706_71293e91-ecee-44ce-b1f4-c7c4b19e3f1c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-959-154335309591515 TABLET, FILM COATED in 1 BOTTLE (43353-959-15) 2015-02-250000-00-00NoNoCurrent
43353-959-454335309594545 TABLET, FILM COATED in 1 BOTTLE (43353-959-45) 2014-08-010000-00-00NoNoCurrent