Atorvastatin calcium

Product NDC
70518-3339
Requested package NDC
70518-3339-1
11-digit product format
705183339
Labeler code
70518
Product ID
70518-3339_4ef3281a-e577-b5c2-e063-6394a90ad3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211933
Marketing category
ANDA
Marketing start
2022-01-23
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 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
A211933-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08
A211933-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08
A211933-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08
A211933-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211933-001AB
A211933-002AB
A211933-003AB
A211933-004AB

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 UTC2026-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2019-02-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2019-02-08d06236e962d9…

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 UTC2026-02A211933-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211933-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211933-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211933-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211933-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211933-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211933-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211933-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211933-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211933-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211933-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211933-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211933-004AB1d06236e962d9…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.52f99e39-fb92-e9f5-e063-6294a90a1b6a2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.5b3c3043-9af6-48eb-8b10-528e58c88e482026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.51e24220-3374-4e5e-9a8d-4113002c5bed2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.b0bbab86-6789-4ffb-8f84-ee91b69fdb342026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
ndc (package): 70518-3339-1
ndc (product): 70518-3339
ndc11 (package): 70518333901
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.9786388d-ac8d-4646-9fe4-b33e8fda86b22026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.e78ba844-97a6-4602-92b6-8190028b826d2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackbf35034d-27ab-4263-a9ed-c7cee1a4fb0a2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.21234914-e1bb-4118-8f81-4ab4a59e9e1e2026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx124c111c-9272-eca9-e063-6394a90a0ad52026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNorthwind Health Company, LLC13b1578a-70cc-6c58-e063-6394a90a0d1b2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackec1d1722-d035-4a8b-b3ab-d2d93f2fd4bb2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepackf1f3e4e0-5407-4831-9885-3a37e72356c02025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.4509aa67-06d4-41d1-80b6-c9bd8ad0bf072025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.46eeb12f-7e38-4828-b7d1-26b6155bc64a2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPD-Rx Pharmaceuticals, Inc.e959b07b-3e6c-44cc-9a6d-c6689d393e4c2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack00afce9b-48c9-487a-a738-e359c005c7072025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMPreferred Pharmaceuticals Inc.4ff0d618-cde4-49ae-8bcb-98dafc3ecdba2025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_rx1ade00fd-5eb4-f67a-e063-6294a90a91122025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMProficient Rx LP9168df23-4260-46be-9556-8b037af0ea282025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b490414a-35e7-fded-e053-2a95a90aca8d2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211933
application number: ANDA211933

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin calcium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
48A5M73Z4QInternal 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
b0bbab86-6789-4ffb-8f84-ee91b69fdb34Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3339-0Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307
70518-3339-1Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3339ATORVASTATIN CALCIUM TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20241004_b0bbab86-6789-4ffb-8f84-ee91b69fdb34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin 20 MG Oral TabletSCDb0bbab86-6789-4ffb-8f84-ee91b69fdb347
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYb0bbab86-6789-4ffb-8f84-ee91b69fdb347

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3339-17051833390130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3339-1) 2023-12-19NoNoCurrent