ATORVASTATIN CALCIUM

Product NDC
43353-120
Requested package NDC
43353-120-60
11-digit product format
433530120
Labeler code
43353
Product ID
43353-120_67dce28b-a634-42eb-b565-93d513ab9b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020702
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-01-28
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-12043353-120-60IInactivated by FDA2026-08-17

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 · 15 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…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020702-001LIPITORATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALABRLD1996-12-17
N020702-002LIPITORATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALABRLD1996-12-17
N020702-003LIPITORATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALABRLD1996-12-17
N020702-004LIPITORATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALABRLD, RS2000-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020702-001AB
N020702-002AB
N020702-003AB
N020702-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020702-004AB1d8e5a09893c0…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N020702-001M-2042020-06-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020702-002M-2042020-06-2374a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020702-001M-2042020-06-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020702-002M-2042020-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020702-001M-2042020-06-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020702-002M-2042020-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020702-001M-2042020-06-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020702-002M-2042020-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09N020702-001M-2042020-06-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020702-002M-2042020-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N020702-001M-2042020-06-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020702-002M-2042020-06-23ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-120-45ATORVASTATIN CALCIUM45 in 1 BOTTLETABLET, FILM COATED454
43353-120-60ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-120-60EA - Each43353-1201f9d1cb1-db76-4716-a7d5-fb9841e1259d12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-120ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 2 package rows20191219_b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipitorATORVASTATIN CALCIUMViatris Specialty LLCa60cc18b-0631-4cf0-b021-9f52224ece652024-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020702
application number: NDA020702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4
617312atorvastatin 10 MG Oral TabletSCDb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-120-604335301206090 TABLET, FILM COATED in 1 BOTTLE (43353-120-60) 2016-01-130000-00-00NoNoCurrent