Atorvastatin Calcium

Product NDC
63739-037
11-digit product format
637390037
Labeler code
63739
Product ID
63739-037_b4ca149c-196d-35b1-e053-2a95a90a8201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Mckesson Corporation DBA SKY Packaginng
Application
ANDA202357
Marketing category
ANDA
Marketing start
2012-07-17
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
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 productproduct63739-037IInactivated by FDA2026-10-05
excluded packagepackage63739-03763739-037-33IInactivated by FDA2026-10-05

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 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 packagepackage63739-037-33d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-037-33f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-037-332ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-037-33a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-037-33cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-037-33cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-037-33302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-037-33ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-037-330efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-037-33ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-037-33367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-037-33557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63739-037-338af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63739-037-33834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63739-037-331332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202357-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202357-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1784e616aacf4f…
2026-08-18 06:07:402026-07A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-173f01610625f2…
2019-09-15 20:21 UTC2019-09A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202357-001ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2012-07-17f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202357-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A202357-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202357-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202357-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202357-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202357-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202357-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202357-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202357-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202357-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202357-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202357-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202357-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202357-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202357-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202357-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202357-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202357-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202357-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202357-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202357-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202357-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202357-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202357-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202357-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202357-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202357-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202357-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202357-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202357-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202357-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202357-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202357-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202357-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202357-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202357-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202357-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202357-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202357-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202357-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-037-33Atorvastatin Calcium3 in 1 CASETABLET35
63739-037-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-037-33EA - Each63739-0379cf79cab-d309-49cc-9661-c4ae5cdc64f112020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-037ATORVASTATIN CALCIUM TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]5Legacy NDC, 2 package rows20211116_74d03dfe-6fe1-42e4-8048-b5b42874da96.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMDr. Reddy's Laboratories Limited6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d2020-11-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202357
application number: ANDA202357

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN74d03dfe-6fe1-42e4-8048-b5b42874da965
259255atorvastatin 80 MG Oral TabletSCD74d03dfe-6fe1-42e4-8048-b5b42874da965
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY74d03dfe-6fe1-42e4-8048-b5b42874da965

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-037-33637390037333 BLISTER PACK in 1 CASE (63739-037-33) > 10 TABLET in 1 BLISTER PACK3 blister pack2020-02-170000-00-00NoNoCurrent