Atorvastatin calcium

Product NDC
70518-3848
11-digit product format
705183848
Labeler code
70518
Product ID
70518-3848_3f8bd7d1-9146-83b0-e063-6394a90aeaa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2023-08-31
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-384870518-3848-1DDiscontinued by firm2026-08-11

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-384870518-3848-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-384870518-3848-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
6600f22e-d303-4fe3-8212-accd6fb06e62Available 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
70518-3848-0Atorvastatin calcium90 in 1 BOTTLE, PLASTICTABLET907
70518-3848-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET307
70518-3848-2Atorvastatin calcium100 in 1 BOTTLE, PLASTICTABLET1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3848ATORVASTATIN CALCIUM TABLET [REMEDYREPACK INC.]5Current NDC, 3 package rows20250322_6600f22e-d303-4fe3-8212-accd6fb06e62.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
ndc (product): 70518-3848
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
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 TabletPSN6600f22e-d303-4fe3-8212-accd6fb06e627
259255atorvastatin 80 MG Oral TabletSCD6600f22e-d303-4fe3-8212-accd6fb06e627
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY6600f22e-d303-4fe3-8212-accd6fb06e627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3848-07051838480090 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0) 90 tablet2023-08-31NoNoCurrent
70518-3848-17051838480130 in 1 BLISTER PACKHistorical
70518-3848-270518384802100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2) 100 tablet2025-03-19NoNoCurrent