Atorvastatin Calcium

Product NDC
68071-2755
11-digit product format
680712755
Labeler code
68071
Product ID
68071-2755_e0e08300-cceb-d1b1-e053-2a95a90ad6c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2755IInactivated by FDA2026-08-17
excluded packagepackage68071-275568071-2755-9IInactivated 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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2755-9IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2755-9IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2755-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2755-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2755-9IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2755-9IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2755-9UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2755-9UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2755-9UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A076477-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30
A076477-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30
A076477-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30
A076477-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30

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 06:07:402026-07A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076477-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-004AB11e350fbaab3a…

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
68071-2755-9Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2755ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220608_e0dfb540-67c3-3303-e053-2995a90a32e7.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2e583569-499d-4f20-87ca-84e7d9868d222026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMSun Pharmaceutical Industries Inc.595ab888-6b55-4642-a32f-e8521821ed812026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.49dcc58a-9f23-045d-e063-6394a90abda62026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXc3b70f79-45a3-0869-e053-2a95a90a3cdb2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackf7af3b3a-b73e-41ee-80e3-2be036672bb72024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b1a840cf-47aa-b931-e053-2a95a90a10472024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPd77e155c-403d-449e-bafd-11c9bd4974dd2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNe0dfb540-67c3-3303-e053-2995a90a32e71
617311atorvastatin 40 MG Oral TabletSCDe0dfb540-67c3-3303-e053-2995a90a32e71
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYe0dfb540-67c3-3303-e053-2995a90a32e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2755-96807127550990 TABLET, FILM COATED in 1 BOTTLE (68071-2755-9) 2022-06-070000-00-00NoNoCurrent