Atorvastatin Calcium

Product NDC
63629-8033
11-digit product format
636298033
Labeler code
63629
Product ID
63629-8033_ddb679cd-caf6-47d8-bd38-baf6a63fc2a9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091624
Marketing category
ANDA
Marketing start
2013-04-05
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-8033DDiscontinued by firm2026-08-10
excluded packagepackage63629-803363629-8033-1DDiscontinued by firm2026-08-10
excluded packagepackage63629-803363629-8033-2DDiscontinued by firm2026-08-10

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 · 36 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 packagepackage63629-8033-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-8033-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-8033-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-8033-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-8033-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-8033-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-8033-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-8033-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-8033-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-8033-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-8033-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-8033-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-8033-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-8033-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-8033-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-8033-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-8033-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-8033-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-8033-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-8033-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-8033-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-8033-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-8033-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-8033-1557ba5c1ecfa…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
A091624-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05
A091624-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05
A091624-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05
A091624-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091624-001AB
A091624-002AB
A091624-003AB
A091624-004AB

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 UTC2026-02A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091624-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2013-04-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2013-04-05d06236e962d9…

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 UTC2026-02A091624-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091624-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091624-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091624-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091624-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091624-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091624-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091624-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091624-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091624-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091624-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091624-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091624-004AB1d06236e962d9…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8033-16362980330130 TABLET, FILM COATED in 1 BOTTLE (63629-8033-1) 2019-07-180000-00-00NoNoCurrent
63629-8033-26362980330290 TABLET, FILM COATED in 1 BOTTLE (63629-8033-2) 2019-07-180000-00-00NoNoCurrent