Atorvastatin Calcium

Product NDC
71335-1010
Requested package NDC
71335-1010-6
11-digit product format
713351010
Labeler code
71335
Product ID
71335-1010_b74ba5ea-e623-4044-a17e-e16428125e73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
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
A076477-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30
A076477-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30
A076477-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30
A076477-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30

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 UTC2026-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORAL2011-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076477-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2011-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2011-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2011-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2011-11-30d06236e962d9…

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
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076477-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076477-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076477-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076477-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076477-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076477-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076477-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076477-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076477-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076477-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076477-004AB11e350fbaab3a…

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
bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8fAvailable 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
71335-1010-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3013
71335-1010-2Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED6013
71335-1010-3Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9013
71335-1010-4Atorvastatin Calcium9 in 1 BOTTLETABLET, FILM COATED913
71335-1010-5Atorvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED2813
71335-1010-6Atorvastatin Calcium20 in 1 BOTTLETABLET, FILM COATED2013
71335-1010-7Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED18013
71335-1010-8Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED10013
71335-1010-9Atorvastatin Calcium7 in 1 BOTTLETABLET, FILM COATED713

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1010-1EA - Each71335-1010280f2acd-fbe8-4dd5-9186-f47c52c512f912020-09-14
71335-1010-3EA - Each71335-1010cc19ee05-ab01-458b-8b42-9d683be679bc12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1010ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 9 package rows20240601_bbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2e583569-499d-4f20-87ca-84e7d9868d222026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMSun Pharmaceutical Industries Inc.595ab888-6b55-4642-a32f-e8521821ed812026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals, Inc.49dcc58a-9f23-045d-e063-6394a90abda62026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMDIRECT RXc3b70f79-45a3-0869-e053-2a95a90a3cdb2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackf7af3b3a-b73e-41ee-80e3-2be036672bb72024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMNuCare Pharmaceuticals,Inc.b1a840cf-47aa-b931-e053-2a95a90a10472024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepackbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f2024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477
ndc (package): 71335-1010-6
ndc (product): 71335-1010
ndc11 (package): 71335101006
Atorvastatin CalciumATORVASTATIN CALCIUMProficient Rx LPd77e155c-403d-449e-bafd-11c9bd4974dd2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076477
application number: ANDA076477

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13
617310atorvastatin 20 MG Oral TabletSCDbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYbbb1a527-3b4d-4fd4-9e38-b231ad5d6d8f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1010-67133510100620 TABLET, FILM COATED in 1 BOTTLE (71335-1010-6) 2024-05-300000-00-00NoNoCurrent