Atorvastatin Calcium

Product NDC
72189-587
Requested package NDC
72189-587-90
11-digit product format
721890587
Labeler code
72189
Product ID
72189-587_2badb650-11cb-a2d3-e063-6294a90a9d14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA214344
Marketing category
ANDA
Marketing start
2024-10-04
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
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
A214344-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12
A214344-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12
A214344-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12
A214344-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214344-001AB
A214344-002AB
A214344-003AB
A214344-004AB

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 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214344-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2023-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2023-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2023-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2023-09-12d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214344-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214344-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214344-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214344-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214344-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214344-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214344-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214344-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214344-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214344-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214344-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214344-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214344-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM 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
23ac06e0-556c-c640-e063-6394a90a931dAvailable 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
72189-587-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
72189-587-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-587-30EA - Each72189-587bcea3663-cd27-4bdb-9ff5-e1445b050c2812024-11-05
72189-587-90EA - Each72189-587aca24be5-5ceb-4b2f-a241-5675c817b2ae12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-587ATORVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX]2Current NDC, 2 package rows20250116_23ac06e0-556c-c640-e063-6394a90a931d.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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMSt. Mary's Medical Park Pharmacy2f76cd3b-fbfa-a193-e063-6294a90a1b322026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMSt. Mary's Medical Park Pharmacy1ea6235f-633c-af0b-e063-6294a90aad6d2026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.200c1994-9327-e02c-e063-6394a90a593d2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsc8b186e4-28c2-4bf9-8964-5a5f3ca3a2da2026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsdb32eb1a-d282-47df-afa2-f250e3c67e712026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMREMEDYREPACK INC.f15094eb-3161-441e-b8ea-c33db2af6b502026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMPreferred Pharmaceuticals, Inc.5327cf20-81e0-4b46-8c86-88c0ddd19c5f2026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMRedpharm Drug301ef8f1-6b5f-234b-e063-6294a90ad2d32025-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions330d488b-794d-416b-8ec7-073946e3fdf52025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsa4185ea4-8fc1-4af5-99b1-6e49f0c464632025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions06abf2dc-5ebd-4d42-b43c-7deeb93925dd2025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions811e6733-fa82-4b41-b426-fe24aa70e6012025-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.1e9151aa-053f-a17d-e063-6294a90afea52025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMQuallent Pharmaceuticals Health LLC5b94b6f4-6f64-4551-abcb-8e845fb138132025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMCamber Pharmaceuticals, Inc.25c8f92f-9cb6-482b-82e1-16ad7c94e7b32025-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.395dbb88-5889-c91c-e063-6394a90a8daf2025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.258d8737-0b80-7d80-e063-6394a90adc8e2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsac98cfd7-fd4c-4fe1-91f3-50a0e232364f2025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions2f84fd12-3e13-47b0-a628-d22a7c4ac3c02025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutions766690b2-9784-4496-9cf3-d5584ae605de2025-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214344
application number: ANDA214344

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN23ac06e0-556c-c640-e063-6394a90a931d2
617310atorvastatin 20 MG Oral TabletSCD23ac06e0-556c-c640-e063-6394a90a931d2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY23ac06e0-556c-c640-e063-6394a90a931d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-587-907218905879090 TABLET, FILM COATED in 1 BOTTLE (72189-587-90) 2024-10-04NoNoCurrent