atorvastatin calcium

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-10-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:51:43

Label at a glance#

Productatorvastatin calcium
Active ingredientATORVASTATIN CALCIUM TRIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1443-3

Atorvastatin Calcium Tablets, USP 10 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 10 mg
Atorvastatin Calcium Tablets, 10 mg

NDC 70771-1444-3

Atorvastatin Calcium Tablets, USP 20 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 20 mg
Atorvastatin Calcium Tablets, 20 mg

NDC 70771-1445-3

Atorvastatin Calcium Tablets, USP 40 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 40 mg
Atorvastatin Calcium Tablets, 40 mg

NDC 70771-1446-3

Atorvastatin Calcium Tablets, USP 80 mg

Rx Only

30 Tablets

Atorvastatin Calcium Tablets, 80 mg
Atorvastatin Calcium Tablets, 80 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1443ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip
70771-1444ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip
70771-1445ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip
70771-1446ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED]6Legacy NDC20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206536-001ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-20
A206536-002ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-20
A206536-003ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-20
A206536-004ATORVASTATIN CALCIUMATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206536-001AB
A206536-002AB
A206536-003AB
A206536-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-2084e616aacf4f…
2026-09-14 22:38:342026-08A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-2084e616aacf4f…
2026-09-14 22:38:342026-08A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-2084e616aacf4f…
2026-09-14 22:38:342026-08A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-2084e616aacf4f…
2026-08-18 06:07:402026-07A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-20caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-001ATORVASTATIN CALCIUMEQ 10MG BASETABLET / ORALAB2018-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-002ATORVASTATIN CALCIUMEQ 20MG BASETABLET / ORALAB2018-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-003ATORVASTATIN CALCIUMEQ 40MG BASETABLET / ORALAB2018-11-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-004ATORVASTATIN CALCIUMEQ 80MG BASETABLET / ORALAB2018-11-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206536-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206536-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206536-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206536-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A206536-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206536-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206536-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206536-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206536-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206536-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206536-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206536-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206536-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206536-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206536-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206536-004AB15bbf6a4d5a75…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
17e443c1-adcb-436d-9a25-99b0a31163cecda119f2-54c8-4a08-b266-a0dbd214d2ce2024-10-21Exact identifier
spl id: 17e443c1-adcb-436d-9a25-99b0a31163ce
spl set id: cda119f2-54c8-4a08-b266-a0dbd214d2ce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.