ATORVASTATIN CALCIUM

Product NDC
71335-1507
11-digit product format
713351507
Labeler code
71335
Product ID
71335-1507_7fff292f-dba8-4613-a8d0-19ea6cd0e6a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-06
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 productproduct71335-1507DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-1DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-2DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-3DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-4DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-5DDiscontinued by firm2026-10-05
excluded packagepackage71335-150771335-1507-6DDiscontinued 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 · 84 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 packagepackage71335-1507-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1507-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1507-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1507-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1507-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-1507-6d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-1507-6f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-1507-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-1507-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-1507-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-1507-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-1507-6302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-1507-6ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1507-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1507-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-1507-20efc9e666f02…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
A207687-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-30
A207687-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-30
A207687-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-30
A207687-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207687-001AB
A207687-002AB
A207687-003AB
A207687-004AB

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 22:38:342026-08A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-03-305bbf6a4d5a75…

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 22:38:342026-08A207687-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207687-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207687-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207687-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A207687-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207687-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207687-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207687-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207687-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207687-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207687-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207687-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207687-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207687-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207687-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207687-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
ATORVASTATIN CALCIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48A5M73Z4QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
617310Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbeb2aa0-24a2-430f-b456-34a4e63e1817Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1507-1ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED30102
71335-1507-2ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED60102
71335-1507-3ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED90102
71335-1507-4ATORVASTATIN CALCIUM9 in 1 BOTTLETABLET, FILM COATED9102
71335-1507-5ATORVASTATIN CALCIUM28 in 1 BOTTLETABLET, FILM COATED28102
71335-1507-6ATORVASTATIN CALCIUM20 in 1 BOTTLETABLET, FILM COATED20102
71335-1507-7ATORVASTATIN CALCIUM180 in 1 BOTTLETABLET, FILM COATED180102
71335-1507-8ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED100102
71335-1507-9ATORVASTATIN CALCIUM7 in 1 BOTTLETABLET, FILM COATED7102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1507ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20241120_cbeb2aa0-24a2-430f-b456-34a4e63e1817.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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.c095d497-0634-6413-e053-2a95a90aa67f2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNorthwind Health Company, LLCdf6233cf-5b4e-5fbe-e053-2a95a90a0a802026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMAccord Healthcare Inc.4e06b20d-cc5d-46eb-991b-5972248de3af2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack1fb2d51e-360c-40a3-8072-f22893890a512024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepackcbeb2aa0-24a2-430f-b456-34a4e63e18172024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ndc (product): 71335-1507
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepackace2c37e-b525-4fe7-8316-9bd3fa4a092c2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.9e014adf-251e-126e-e053-2995a90a05bf2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.a0835fa8-bd55-33bd-e053-2a95a90a96b12024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.a0732bc4-702d-f566-e053-2a95a90a1d692024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPa1b22973-cb9a-473e-a240-112b3e84e97c2022-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LPe931003a-3a8d-48b9-b13f-e620017303f62022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMProficient Rx LP1923c91e-c6dd-4446-aabd-70a0c6aa1a822022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207687
application number: ANDA207687

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNcbeb2aa0-24a2-430f-b456-34a4e63e1817102
617310atorvastatin 20 MG Oral TabletSCDcbeb2aa0-24a2-430f-b456-34a4e63e1817102
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYcbeb2aa0-24a2-430f-b456-34a4e63e1817102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1507-17133515070130 TABLET, FILM COATED in 1 BOTTLE (71335-1507-1) 2020-02-100000-00-00NoNoCurrent
71335-1507-27133515070260 TABLET, FILM COATED in 1 BOTTLE (71335-1507-2) 2020-03-160000-00-00NoNoCurrent
71335-1507-37133515070390 TABLET, FILM COATED in 1 BOTTLE (71335-1507-3) 2020-02-250000-00-00NoNoCurrent
71335-1507-4713351507049 TABLET, FILM COATED in 1 BOTTLE (71335-1507-4) 2024-10-310000-00-00NoNoCurrent
71335-1507-57133515070528 TABLET, FILM COATED in 1 BOTTLE (71335-1507-5) 2024-10-310000-00-00NoNoCurrent
71335-1507-67133515070620 TABLET, FILM COATED in 1 BOTTLE (71335-1507-6) 2024-10-310000-00-00NoNoCurrent
71335-1507-771335150707180 TABLET, FILM COATED in 1 BOTTLE (71335-1507-7) 2024-10-310000-00-00NoNoCurrent
71335-1507-871335150708100 TABLET, FILM COATED in 1 BOTTLE (71335-1507-8) 2024-10-31NoNoCurrent
71335-1507-9713351507097 TABLET, FILM COATED in 1 BOTTLE (71335-1507-9) 2024-10-31NoNoCurrent