Atorvastatin Calcium

Product NDC
71335-1247
11-digit product format
713351247
Labeler code
71335
Product ID
71335-1247_b568747b-5987-413c-a70e-496081c29df3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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 productproduct71335-1247DDiscontinued by firm2026-08-17
excluded packagepackage71335-124771335-1247-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-124771335-1247-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-124771335-1247-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-124771335-1247-4DDiscontinued by firm2026-08-17

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 · 60 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 packagepackage71335-1247-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1247-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1247-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1247-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1247-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1247-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1247-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1247-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1247-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1247-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1247-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1247-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1247-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1247-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1247-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1247-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1247-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1247-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1247-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1247-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1247-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1247-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1247-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1247-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1247-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1247-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1247-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1247-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1247-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1247-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1247-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1247-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1247-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1247-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1247-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1247-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1247-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1247-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1247-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1247-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1247-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1247-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1247-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1247-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1247-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1247-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1247-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1247-4557ba5c1ecfa…9c80585c8c6e…

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
A209288-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21
A209288-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21
A209288-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21
A209288-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209288-001AB
A209288-002AB
A209288-003AB
A209288-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209288-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209288-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209288-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004AB1d8e5a09893c0…

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 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.09cb8375-075c-47e8-a4eb-8ac667ed849e2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCc9f55cb6-a41b-dd27-e053-2a95a90aaeb72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCf3084cae-db82-4e6f-e053-2995a90aa36a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCda6b77a5-2093-b7f7-e053-2995a90ab10d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.bd216f5d-f319-7d8d-e053-2a95a90aa9ce2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.c0e2a5d0-1aa3-e131-e053-2a95a90a98702025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.57f9b462-f08e-483c-9b64-b7e4c8d469272025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAsclemed USA, Inc.60d51f39-8086-4434-affe-88ab8ca0c7e52025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAscend Laboratories, LLC67e60880-091a-4df7-8696-6e6c42a490e22025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2035c49b-f319-4dce-bf1c-c2f64e786fb72025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.95729689-8055-45ae-e053-2995a90a919f2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.8ee8b455-625c-ead6-e053-2a95a90aed292024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f9f27-c645-2d2e-e053-2991aa0a96b92024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f58d1-476c-2c90-e053-2991aa0ab8212024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions1cc2dd41-a465-45b6-a80a-67c41af29cf82024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions2ad89657-cc95-44a0-af6a-ee756526aa102024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions103cc381-3266-409d-bdc2-1de620bae3552024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse52b4b11-9618-4787-ae67-44e4a3166dfb2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions0ec97c59-9d17-45f8-93f9-2c1f0361cb752024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse6d068ed-f9d2-4fd1-9755-b76bea89725e2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1247-17133512470130 TABLET, FILM COATED in 1 BOTTLE (71335-1247-1) 2022-09-230000-00-00NoNoCurrent
71335-1247-27133512470260 TABLET, FILM COATED in 1 BOTTLE (71335-1247-2) 2022-09-230000-00-00NoNoCurrent
71335-1247-37133512470390 TABLET, FILM COATED in 1 BOTTLE (71335-1247-3) 2019-06-140000-00-00NoNoCurrent
71335-1247-471335124704180 TABLET, FILM COATED in 1 BOTTLE (71335-1247-4) 2022-09-230000-00-00NoNoCurrent