Atorvastatin Calcium

Product NDC
68071-2452
11-digit product format
680712452
Labeler code
68071
Product ID
68071-2452_c4fd47d5-4a9f-efb0-e053-2995a90a58cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA204991
Marketing category
ANDA
Marketing start
2020-09-24
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2452IInactivated by FDA2026-08-17
excluded packagepackage68071-245268071-2452-9IInactivated 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 · 30 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 packagepackage68071-2452-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2452-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2452-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2452-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2452-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2452-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2452-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2452-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2452-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2452-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2452-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2452-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-2452-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-2452-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-2452-91332a3947898…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
A204991-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06
A204991-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06
A204991-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06
A204991-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06

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 06:07:402026-07A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204991-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2019-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204991-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2019-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204991-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2019-03-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204991-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2019-03-06d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 112 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204991-001BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204991-002BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204991-003BX179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204991-004BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204991-001BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204991-002BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204991-003BX1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204991-004BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204991-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204991-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204991-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204991-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204991-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204991-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204991-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204991-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204991-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204991-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204991-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204991-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204991-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204991-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204991-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204991-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204991-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204991-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204991-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204991-004AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A204991-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204991-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204991-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204991-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204991-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204991-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204991-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204991-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204991-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204991-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204991-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204991-004AB187673890dc5c…

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
68071-2452-9Atorvastatin Calcium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2452ATORVASTATIN CALCIUM TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210618_c4fd47d5-4a9e-efb0-e053-2995a90a58cc.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXc3b70f79-45a3-0869-e053-2a95a90a3cdb2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack5868d3c2-ae17-4a7e-9580-7c3cf9bf009e2024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991
Atorvastatin CalciumATORVASTATIN CALCIUMLupin Pharmaceuticals, Inc.a5767370-15a2-45e5-b980-7af9523aea7b2023-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions85c38e0b-3d0b-4b04-990a-ed077a4c43e42023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionsd3f27113-785c-419e-955a-d6782fade4382023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionsf4154300-65d4-4e31-97ad-b8d086c676e22023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204991
application number: ANDA204991

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNc4fd47d5-4a9e-efb0-e053-2995a90a58cc1
617310atorvastatin 20 MG Oral TabletSCDc4fd47d5-4a9e-efb0-e053-2995a90a58cc1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYc4fd47d5-4a9e-efb0-e053-2995a90a58cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2452-96807124520990 TABLET in 1 BOTTLE (68071-2452-9) 90 tablet2021-06-170000-00-00NoNoCurrent