Home DailyMed cda119f2-54c8-4a08-b266-a0dbd214d2ce atorvastatin calcium Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
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# Product atorvastatin calcium
Active ingredient ATORVASTATIN CALCIUM TRIHYDRATE
Label structure 1 sections
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1443 ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip 70771-1444 ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip 70771-1445 ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20241023_cda119f2-54c8-4a08-b266-a0dbd214d2ce.zip 70771-1446 ATORVASTATIN CALCIUM TABLET [ZYDUS LIFESCIENCES LIMITED] 6 Legacy NDC 20241023_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.
atorvastatin calcium ATORVASTATIN CALCIUM TRIHYDRATE ATORVASTATIN CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (110000 WAMW) HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE TALC CELLULOSE SODIUM PHOSPHATE NDC Codes# Product NDC, Package NDC table Product NDC Package NDC 70771-1443 70771-1443-4 , 70771-1443-3 , 70771-1443-9 , 70771-1443-1 , 70771-1443-5 , 70771-1443-0 70771-1444 70771-1444-9 , 70771-1444-1 , 70771-1444-5 , 70771-1444-0 , 70771-1444-4 , 70771-1444-3 70771-1445 70771-1445-9 , 70771-1445-1 , 70771-1445-5 , 70771-1445-0 , 70771-1445-4 , 70771-1445-3 70771-1446 70771-1446-9 , 70771-1446-1 , 70771-1446-5 , 70771-1446-0 , 70771-1446-4 , 70771-1446-3
Ingredients# Every source-derived ingredient row is available through these pages.
DailyMed ingredient rows page 1 of 2 · 48 matching rows.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206536-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 A206536-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 A206536-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 A206536-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206536-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206536-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206536-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206536-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-11-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.