ATORVASTATIN CALCIUM

Product NDC
63629-4849
11-digit product format
636294849
Labeler code
63629
Product ID
63629-4849_a3c8dc3a-6fc3-4115-a00e-139ec72c1b34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020702
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-11-30
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4849DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-1DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-2DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-3DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-4DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-5DDiscontinued by firm2026-10-05
excluded packagepackage63629-484963629-4849-6DDiscontinued by firm2026-10-05

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 2 · 96 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 packagepackage63629-4849-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4849-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4849-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4849-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4849-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4849-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4849-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4849-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4849-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4849-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4849-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4849-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4849-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4849-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4849-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4849-20efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020702-001LIPITORATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALABRLD1996-12-17
N020702-002LIPITORATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALABRLD1996-12-17
N020702-003LIPITORATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALABRLD1996-12-17
N020702-004LIPITORATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALABRLD, RS2000-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020702-001AB
N020702-002AB
N020702-003AB
N020702-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1784e616aacf4f…
2026-09-14 22:38:342026-08N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001LIPITOREQ 10MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002LIPITOREQ 20MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003LIPITOREQ 40MG BASETABLET / ORALABRLD1996-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004LIPITOREQ 80MG BASETABLET / ORALABRLD, RS2000-04-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020702-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N020702-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N020702-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020702-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020702-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020702-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020702-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020702-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020702-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020702-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020702-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020702-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020702-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020702-004AB15bbf6a4d5a75…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N020702-001M-2042020-06-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020702-002M-2042020-06-2374a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020702-001M-2042020-06-238869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020702-002M-2042020-06-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020702-001M-2042020-06-23c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020702-002M-2042020-06-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020702-001M-2042020-06-233f01610625f2…
2019-12-14 00:12 UTC2019-12N020702-002M-2042020-06-233f01610625f2…
2019-09-15 20:21 UTC2019-09N020702-001M-2042020-06-23b00525d2431f…
2019-09-15 20:21 UTC2019-09N020702-002M-2042020-06-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N020702-001M-2042020-06-23ea99ee380514…
2019-07-19 19:46 UTC2019-07N020702-002M-2042020-06-23ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4849-12021-06-01These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
63629-4849-22021-06-01These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
63629-4849-32021-06-01These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
63629-4849-12019-11-27These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
63629-4849-22019-11-27These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996
63629-4849-32019-11-27These highlights do not include all the information needed to use atorvastatin calcium tablets safely and effectively. See full prescribing information for atorvastatin calcium tablets. Atorvastatin Calcium Tablets for oral administration Initial U.S. Approval: 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipitorATORVASTATIN CALCIUMViatris Specialty LLCa60cc18b-0631-4cf0-b021-9f52224ece652024-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020702
application number: NDA020702