Atorvastatin Calcium

Product NDC
67296-1620
11-digit product format
672961620
Labeler code
67296
Product ID
67296-1620_b8d0796c-80c4-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA091624
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1620IInactivated by FDA2026-08-10
excluded packagepackage67296-162067296-1620-3IInactivated by FDA2026-08-10

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 · 30 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 packagepackage67296-1620-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1620-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1620-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1620-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1620-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1620-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1620-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1620-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1620-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1620-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1620-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1620-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1620-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1620-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1620-31332a3947898…d4bfe170f9cd…

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…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1620-32023-01-30C16284748780-1f386c649-af41-0266-e053-dadaa90a7c1aATORVASTATIN 40MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1620-3Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1620ATORVASTATIN CALCIUM TABLET, FILM COATED [REDPHARM DRUG, INC.]7Legacy NDC, 1 package rows20210114_888a969b-95e0-296c-e053-2995a90afa24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN888a969b-95e0-296c-e053-2995a90afa247
617311atorvastatin 40 MG Oral TabletSCD888a969b-95e0-296c-e053-2995a90afa247
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY888a969b-95e0-296c-e053-2995a90afa247

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1620-36729616200330 TABLET, FILM COATED in 1 BOTTLE (67296-1620-3) 2019-01-010000-00-00NoNoCurrent