Atorvastatin calcium

Product NDC
71335-9646
11-digit product format
713359646
Labeler code
71335
Product ID
71335-9646_7218b0fa-38bf-43ed-b851-94e0e26ebb09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213853
Marketing category
ANDA
Marketing start
2020-08-26
Substance
ATORVASTATIN
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN80 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
259255Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
112ae40c-b612-405b-8f68-6d4bf09f9440Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-9646-1Atorvastatin calcium30 in 1 BOTTLETABLET30105
71335-9646-2Atorvastatin calcium60 in 1 BOTTLETABLET60105
71335-9646-3Atorvastatin calcium90 in 1 BOTTLETABLET90105
71335-9646-4Atorvastatin calcium180 in 1 BOTTLETABLET180105
71335-9646-5Atorvastatin calcium100 in 1 BOTTLETABLET100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9646ATORVASTATIN CALCIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, 5 package rows20250303_112ae40c-b612-405b-8f68-6d4bf09f9440.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
ndc (product): 71335-9646
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
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
259255atorvastatin calcium 80 MG Oral TabletPSN112ae40c-b612-405b-8f68-6d4bf09f9440105
259255atorvastatin 80 MG Oral TabletSCD112ae40c-b612-405b-8f68-6d4bf09f9440105
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY112ae40c-b612-405b-8f68-6d4bf09f9440105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9646-17133596460130 TABLET in 1 BOTTLE (71335-9646-1) 30 tablet2023-06-29NoNoCurrent
71335-9646-27133596460260 TABLET in 1 BOTTLE (71335-9646-2) 60 tablet2026-04-13NoNoCurrent
71335-9646-37133596460390 TABLET in 1 BOTTLE (71335-9646-3) 90 tablet2023-02-09NoNoCurrent
71335-9646-471335964604180 TABLET in 1 BOTTLE (71335-9646-4) 180 tablet2026-04-13NoNoCurrent
71335-9646-571335964605100 TABLET in 1 BOTTLE (71335-9646-5) 100 tablet2026-04-13NoNoCurrent