Atorvastatin calcium

Product NDC
60290-040
11-digit product format
602900040
Labeler code
60290
Product ID
60290-040_4999f880-cf37-837f-e063-6394a90a72d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA213853
Marketing category
ANDA
Marketing start
2026-02-15
Substance
ATORVASTATIN
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
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
ATORVASTATIN20 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259255Internal RxNorm lookup
617310Internal RxNorm lookup
617311Internal RxNorm lookup
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
5a7594ca-30be-4350-827f-ef745a2a7e18Available 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
60290-040-01Atorvastatin calcium90 in 1 BOTTLETABLET901
60290-040-02Atorvastatin calcium1000 in 1 BOTTLETABLET10001
60290-040-03Atorvastatin calcium5000 in 1 BOTTLETABLET50001
60290-040-04Atorvastatin calcium500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60290-040-01EA - Each60290-040dcf2ce29-da66-492a-8f73-ac4b153768de12026-05-22
60290-040-02EA - Each60290-040be78a3b8-8cef-4896-b53c-cff55bda452212026-05-22

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
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
ndc (product): 60290-040
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
617312atorvastatin calcium 10 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin calcium 20 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin calcium 40 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin calcium 80 MG Oral TabletPSN5a7594ca-30be-4350-827f-ef745a2a7e181
617312atorvastatin 10 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin 20 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin 40 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin 80 MG Oral TabletSCD5a7594ca-30be-4350-827f-ef745a2a7e181
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY5a7594ca-30be-4350-827f-ef745a2a7e181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-040-016029000400190 TABLET in 1 BOTTLE (60290-040-01) 90 tablet2026-02-15NoNoCurrent
60290-040-02602900040021000 TABLET in 1 BOTTLE (60290-040-02) 1000 tablet2026-02-15NoNoCurrent
60290-040-03602900040035000 TABLET in 1 BOTTLE (60290-040-03) 5000 tablet2026-02-15NoNoCurrent
60290-040-0460290004004500 TABLET in 1 BOTTLE (60290-040-04) 500 tablet2026-02-15NoNoCurrent