Atorvastatin Calcium

Product NDC
71335-2241
Requested package NDC
71335-2241-2
11-digit product format
713352241
Labeler code
71335
Product ID
71335-2241_e21371a6-df28-41fb-b855-aaa4c1950731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209288
Marketing category
ANDA
Marketing start
2018-12-23
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 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

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
A209288-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21
A209288-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21
A209288-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21
A209288-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209288-001AB
A209288-002AB
A209288-003AB
A209288-004AB

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 UTC2026-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209288-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-12-21d06236e962d9…

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 UTC2026-02A209288-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209288-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209288-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209288-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209288-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209288-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209288-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209288-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209288-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209288-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209288-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209288-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209288-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Atorvastatin Calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE10 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
617312Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2035c49b-f319-4dce-bf1c-c2f64e786fb7Available 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
71335-2241-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED30104
71335-2241-2Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED90104
71335-2241-3Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED60104
71335-2241-4Atorvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED120104
71335-2241-5Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED100104
71335-2241-6Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED180104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2241ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, 6 package rows20250228_2035c49b-f319-4dce-bf1c-c2f64e786fb7.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.09cb8375-075c-47e8-a4eb-8ac667ed849e2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCc9f55cb6-a41b-dd27-e053-2a95a90aaeb72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCf3084cae-db82-4e6f-e053-2995a90aa36a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNorthwind Health Company, LLCda6b77a5-2093-b7f7-e053-2995a90ab10d2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.bd216f5d-f319-7d8d-e053-2a95a90aa9ce2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMQPharma, Inc.c0e2a5d0-1aa3-e131-e053-2a95a90a98702025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.57f9b462-f08e-483c-9b64-b7e4c8d469272025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAsclemed USA, Inc.60d51f39-8086-4434-affe-88ab8ca0c7e52025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMAscend Laboratories, LLC67e60880-091a-4df7-8696-6e6c42a490e22025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2035c49b-f319-4dce-bf1c-c2f64e786fb72025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
ndc (package): 71335-2241-2
ndc (product): 71335-2241
ndc11 (package): 71335224102
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.95729689-8055-45ae-e053-2995a90a919f2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.8ee8b455-625c-ead6-e053-2a95a90aed292024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f9f27-c645-2d2e-e053-2991aa0a96b92024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.862f58d1-476c-2c90-e053-2991aa0ab8212024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions1cc2dd41-a465-45b6-a80a-67c41af29cf82024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions2ad89657-cc95-44a0-af6a-ee756526aa102024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions103cc381-3266-409d-bdc2-1de620bae3552024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse52b4b11-9618-4787-ae67-44e4a3166dfb2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutions0ec97c59-9d17-45f8-93f9-2c1f0361cb752024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288
Atorvastatin CalciumATORVASTATIN CALCIUMA-S Medication Solutionse6d068ed-f9d2-4fd1-9755-b76bea89725e2024-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209288
application number: ANDA209288

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin 10 MG Oral TabletSCD2035c49b-f319-4dce-bf1c-c2f64e786fb7104
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY2035c49b-f319-4dce-bf1c-c2f64e786fb7104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2241-27133522410290 TABLET, FILM COATED in 1 BOTTLE (71335-2241-2) 2023-10-10NoNoCurrent