Atorvastatin calcium

Product NDC
67046-1529
Requested package NDC
67046-1529-3
11-digit product format
670461529
Labeler code
67046
Product ID
67046-1529_2fffae44-e508-9645-e063-6394a90a7ce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Coupler LLC
Application
ANDA217081
Marketing category
ANDA
Marketing start
2025-03-10
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 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
A217081-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05
A217081-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05
A217081-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05
A217081-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217081-001AB
A217081-002AB
A217081-003AB
A217081-004AB

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 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217081-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2024-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2024-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2024-01-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2024-01-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217081-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217081-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217081-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217081-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217081-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217081-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217081-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217081-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217081-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217081-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217081-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217081-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE40 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
617311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fffae44-e536-9645-e063-6394a90a7ce5Available 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
67046-1529-3Atorvastatin calcium30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1529ATORVASTATIN CALCIUM TABLET, FILM COATED [COUPLER LLC]1Current NDC, 1 package rows20250311_2fffae44-e536-9645-e063-6394a90a7ce5.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx56a9e58f-567e-30cc-e063-6294a90a290f2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.bd26679f-f8ff-41d2-a384-bd1f66f8a6142026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.61c29f52-7dcd-44ac-a8aa-4f54f0901f042026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.8cc6240a-58d3-4bca-aa1e-662228957f752026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.f7bb4aac-f716-4dd9-a6d7-6f37e865b8432026-03-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMST. MARY'S MEDICAL PARK PHARMACY2e20a00c-b373-3a8c-e063-6294a90a637b2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.4847b761-30a5-0a1a-e063-6294a90ad02b2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC3eee2ddb-851e-15ad-e063-6394a90a173a2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMNorthStar RxLLC85fbaf22-017b-4163-b33e-c6594994859b2025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMST. MARY'S MEDICAL PARK PHARMACY31ccef91-ca32-61be-e063-6394a90a10652025-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2fffae44-e536-9645-e063-6394a90a7ce52025-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
ndc (package): 67046-1529-3
ndc (product): 67046-1529
ndc11 (package): 67046152903
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2cd9999b-e18f-09de-e063-6294a90a108b2025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2c67a15c-53b7-f431-e063-6394a90acc502025-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081
Atorvastatin calciumATORVASTATIN CALCIUMLifestar Pharma LLCde8f2c55-44d2-4e01-b7f2-dfb24f1f87602024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217081
application number: ANDA217081

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN2fffae44-e536-9645-e063-6394a90a7ce51
617311atorvastatin 40 MG Oral TabletSCD2fffae44-e536-9645-e063-6394a90a7ce51
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY2fffae44-e536-9645-e063-6394a90a7ce51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1529-36704615290330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1529-3) 2025-03-10NoNoCurrent