atorvastatin calcium

Product NDC
68645-592
Requested package NDC
68645-592-54
11-digit product format
686450592
Labeler code
68645
Product ID
68645-592_a89e46e9-689a-4701-8289-559ef0459397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging, LLC
Application
ANDA209912
Marketing category
ANDA
Marketing start
2018-06-18
Marketing end
2021-06-30
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
0000-00-00
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 packagepackage68645-59268645-592-54DDiscontinued 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 · 12 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…

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
A209912-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18
A209912-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18
A209912-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18
A209912-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209912-001AB
A209912-002AB
A209912-003AB
A209912-004AB

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 UTC2026-02A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209912-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-06-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-06-18d06236e962d9…

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 UTC2026-02A209912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209912-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209912-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209912-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209912-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209912-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209912-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209912-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209912-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209912-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209912-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209912-004AB1d06236e962d9…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-592-54EA - Each68645-5929673c6c0-c0ec-41b5-a5fd-450dd6209ec312020-02-13

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.a92f2742-1763-4a02-94b7-e8db714eb2f42026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.4344f574-9b86-7ae5-e063-6294a90a79e82025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.7fc58ce3-f069-409b-b36f-bb23ce21fb6f2025-09-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.3ef3b6e3-83dc-e06a-e063-6394a90a152c2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDRising Pharma Holdings, Inc.73cefb0b-1747-4fe0-b252-377f4ed94c6f2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals, Inc.3bde7950-3d25-a86e-e063-6394a90ae6232025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack9c58c4cd-fe1c-4db7-832c-874766e4da212025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.3778125d-b3d9-2853-e063-6394a90aa8632025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepackb8fa04f5-0d56-49ca-bb01-f0dd3b4721642025-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack17f779f2-48ac-4719-bf37-0ee162f911442025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDPreferred Pharmaceuticals Inc.bb825db4-3798-4d69-8559-46b3ab0c8bd92025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
atorvastatin calciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.faba7fc1-2e08-74ef-e053-6394a90afd042025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
atorvastatin calciumATORVASTATIN CALCIUM, FILM COATEDNuCare Pharmaceuticals,Inc.0a9d4e36-305a-2120-e063-6294a90a01bd2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912
Atorvastatin CalciumATORVASTATIN CALCIUM, FILM COATEDBryant Ranch Prepack32b40825-6b0b-4025-86f5-b4e453efea922024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209912
application number: ANDA209912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68645-592-546864505925430 TABLET in 1 BOTTLE (68645-592-54) 30 tablet2018-06-182021-06-30NoNoCurrent