ATORVASTATIN CALCIUM

Product NDC
72189-291
Requested package NDC
72189-291-90
11-digit product format
721890291
Labeler code
72189
Product ID
72189-291_2c2947eb-f8b1-c0f8-e063-6394a90aa6f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA213853
Marketing category
ANDA
Marketing start
2021-11-10
Substance
ATORVASTATIN
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

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-29172189-291-90UExcluded because listing certification expiredexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-29172189-291-90UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
A213853-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2020-08-19
A213853-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2020-08-19
A213853-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2020-08-19
A213853-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2020-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213853-001AB
A213853-002AB
A213853-003AB
A213853-004AB

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 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213853-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALBX2020-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALBX2020-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALBX2020-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALBX2020-08-19d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213853-001BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-002BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-003BX1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213853-004BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-001BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-002BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-003BX131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213853-004BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213853-001BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-002BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-003BX16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213853-004BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-001BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-002BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-003BX1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213853-004BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-001BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-002BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-003BX1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213853-004BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-001BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-002BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-003BX103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213853-004BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-001BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-002BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-003BX12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213853-004BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-001BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-002BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-003BX15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213853-004BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-001BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-002BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-003BX1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213853-004BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213853-001BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-002BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-003BX1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213853-004BX1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
A0JWA85V8FInternal 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
d076309f-313a-1c71-e053-2995a90a7bb7Available 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
72189-291-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-291-90EA - Each72189-2916936489a-6576-438e-b77a-c15043a6366812021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-291ATORVASTATIN CALCIUM TABLET [DIRECTRX]2Current NDC, Legacy NDC, 1 package rows20250121_d076309f-313a-1c71-e053-2995a90a7bb7.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 CALCIUMREMEDYREPACK INC.6600f22e-d303-4fe3-8212-accd6fb06e622026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.8821431a-c387-4b75-9540-f92bd455e9612026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack20f820ba-9600-4b51-bf23-8c99e815674c2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack112ae40c-b612-405b-8f68-6d4bf09f94402026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx0e24e7cb-1949-6686-e063-6394a90a47602026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMUmedica Laboratories USA Inc.5a7594ca-30be-4350-827f-ef745a2a7e182026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMNIVAGEN PHARMACEUTICALS, INC.7c58bf4a-4a92-4db8-89bc-4de1b5831efc2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.604a011e-6c64-4895-8f6e-d28f119c4c222025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack71cd9b85-4914-4b0b-97db-7aaf259832112025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDirectRXd076309f-313a-1c71-e053-2995a90a7bb72025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
ndc (package): 72189-291-90
ndc (product): 72189-291
ndc11 (package): 72189029190
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.f7e8c8d2-b74e-6afd-e053-6394a90af83e2024-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853
Atorvastatin calciumATORVASTATIN CALCIUMProficient Rx LPacbbd2c4-60bd-4e01-ad7a-b9b3178569f02024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213853
application number: ANDA213853

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNd076309f-313a-1c71-e053-2995a90a7bb72
617310atorvastatin 20 MG Oral TabletSCDd076309f-313a-1c71-e053-2995a90a7bb72
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYd076309f-313a-1c71-e053-2995a90a7bb72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-291-907218902919090 TABLET in 1 BOTTLE (72189-291-90) 90 tablet2021-11-100000-00-00NoNoCurrent