Atorvastatin calcium

Product NDC
69539-095
11-digit product format
695390095
Labeler code
69539
Product ID
69539-095_4bb92478-91aa-4be6-8e3a-4162b22dea25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MSN LABORATORIES PRIVATE LIMITED
Application
ANDA211933
Marketing category
ANDA
Marketing start
2019-02-08
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69539-095DDiscontinued by firm2026-08-03
excluded packagepackage69539-09569539-095-05DDiscontinued by firm2026-08-03
excluded packagepackage69539-09569539-095-30DDiscontinued by firm2026-08-03
excluded packagepackage69539-09569539-095-90DDiscontinued by firm2026-08-03
excluded packagepackage69539-09569539-095-99DDiscontinued by firm2026-08-03

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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69539-095-99
excluded packagepackage69539-095-30
excluded packagepackage69539-095-90
excluded packagepackage69539-095-05

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
A211933-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08
A211933-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08
A211933-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08
A211933-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211933-001AB
A211933-002AB
A211933-003AB
A211933-004AB

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 UTC2026-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d06236e962d9…

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 UTC2026-02A211933-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004AB1d06236e962d9…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69539-095ATORVASTATIN CALCIUM TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]12Legacy NDC20240614_99eba422-e3d9-4e49-b4b4-3be6af258baa.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.52f99e39-fb92-e9f5-e063-6294a90a1b6a2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.5b3c3043-9af6-48eb-8b10-528e58c88e482026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.51e24220-3374-4e5e-9a8d-4113002c5bed2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.b0bbab86-6789-4ffb-8f84-ee91b69fdb342026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.9786388d-ac8d-4646-9fe4-b33e8fda86b22026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.e78ba844-97a6-4602-92b6-8190028b826d2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackbf35034d-27ab-4263-a9ed-c7cee1a4fb0a2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.21234914-e1bb-4118-8f81-4ab4a59e9e1e2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx124c111c-9272-eca9-e063-6394a90a0ad52026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNorthwind Health Company, LLC13b1578a-70cc-6c58-e063-6394a90a0d1b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackf1f3e4e0-5407-4831-9885-3a37e72356c02025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.4509aa67-06d4-41d1-80b6-c9bd8ad0bf072025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.46eeb12f-7e38-4828-b7d1-26b6155bc64a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.e959b07b-3e6c-44cc-9a6d-c6689d393e4c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack00afce9b-48c9-487a-a738-e359c005c7072025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.4ff0d618-cde4-49ae-8bcb-98dafc3ecdba2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_rx1ade00fd-5eb4-f67a-e063-6294a90a91122025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMProficient Rx LP9168df23-4260-46be-9556-8b037af0ea282025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b490414a-35e7-fded-e053-2a95a90aca8d2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69539-095-0569539009505500 TABLET, FILM COATED in 1 BOTTLE (69539-095-05) 2019-02-080000-00-00NoNoCurrent
69539-095-306953900953030 TABLET, FILM COATED in 1 BOTTLE (69539-095-30) 2019-02-080000-00-00NoNoCurrent
69539-095-906953900959090 TABLET, FILM COATED in 1 BOTTLE (69539-095-90) 2019-02-080000-00-00NoNoCurrent
69539-095-99695390095991000 TABLET, FILM COATED in 1 BOTTLE (69539-095-99) 2021-05-100000-00-00NoNoCurrent