Atorvastatin Calcium

Product NDC
43598-833
11-digit product format
435980833
Labeler code
43598
Product ID
43598-833_14581fb9-c75a-8300-dffc-732f7533a1ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA214659
Marketing category
ANDA
Marketing start
2022-08-29
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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
A214659-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14
A214659-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14
A214659-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14
A214659-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214659-001AB
A214659-002AB
A214659-003AB
A214659-004AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214659-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2021-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2021-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2021-07-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2021-07-14d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214659-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214659-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214659-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214659-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214659-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214659-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214659-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214659-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214659-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214659-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214659-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214659-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214659-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATORVASTATIN CALCIUM TRIHYDRATE80 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 · 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
652f77a0-2145-896d-c760-e99e87507161Available 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
43598-833-05Atorvastatin Calcium500 in 1 BOTTLETABLET5008
43598-833-79Atorvastatin Calcium10 in 1 BLISTER PACKTABLET108
43598-833-81Atorvastatin Calcium3 in 1 CARTONTABLET38
43598-833-90Atorvastatin Calcium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-833-05EA - Each43598-8331150ea3d-6265-4e87-90b1-6fcd7c8f352e12022-11-07
43598-833-90EA - Each43598-83398799de4-a0ce-44c7-a288-b9947e8b2d3512022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-833ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES INC]8Current NDC, Legacy NDC, 4 package rows20240612_652f77a0-2145-896d-c760-e99e87507161.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMDr. Reddy's Laboratories Incaaf960d1-8bf9-64c6-1e70-8aa33b0ce5492026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.632ddd78-9e76-4230-944d-dff85d9452382026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.a519e355-84f0-40d1-b586-e6e8eadb5b0f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMCoupler LLC2d916667-7b3e-ea20-e063-6294a90a52da2025-02-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMCoupler LLC2c658654-87ee-b52a-e063-6294a90a11d62025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepacka20bac35-a3d7-4e97-95c2-2502107d61c22024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack9c435528-4c44-44c6-bb10-049a72533c2f2024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepacka33838d7-4e5e-4079-9d3d-00c2048cf7762024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.fa2d8d38-dbd0-43fd-e053-6294a90a4e942024-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
Atorvastatin CalciumATORVASTATIN CALCIUMDr. Reddy's Laboratories Inc652f77a0-2145-896d-c760-e99e875071612024-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214659
application number: ANDA214659
ndc (product): 43598-833

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN9c435528-4c44-44c6-bb10-049a72533c2f101
259255atorvastatin 80 MG Oral TabletSCD9c435528-4c44-44c6-bb10-049a72533c2f101
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY9c435528-4c44-44c6-bb10-049a72533c2f101
617312atorvastatin calcium 10 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin calcium 20 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin calcium 40 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin calcium 80 MG Oral TabletPSN652f77a0-2145-896d-c760-e99e875071618
617312atorvastatin 10 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin 20 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin 40 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin 80 MG Oral TabletSCD652f77a0-2145-896d-c760-e99e875071618
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY652f77a0-2145-896d-c760-e99e875071618
259255atorvastatin calcium 80 MG Oral TabletPSN266d62d0-dd2b-32a4-e063-6394a90a2e5e1
259255atorvastatin 80 MG Oral TabletSCD266d62d0-dd2b-32a4-e063-6394a90a2e5e1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY266d62d0-dd2b-32a4-e063-6394a90a2e5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-833-0543598083305500 TABLET in 1 BOTTLE (43598-833-05) 500 tablet2022-08-290000-00-00NoNoCurrent
43598-833-794359808337910 in 1 BLISTER PACKHistorical
43598-833-81435980833813 BLISTER PACK in 1 CARTON (43598-833-81) / 10 TABLET in 1 BLISTER PACK (43598-833-79) 3 blister pack2022-08-290000-00-00NoNoCurrent
43598-833-904359808339090 TABLET in 1 BOTTLE (43598-833-90) 90 tablet2022-08-290000-00-00NoNoCurrent