Home NDC 0781-5384 Atorvastatin Calcium
Product NDC 0781-5384
11-digit product format 007815384
Labeler code 0781
Product ID 0781-5384_0810bbbb-d9a2-4ed1-8bb3-38329d31c805
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atorvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA077575
Marketing category ANDA
Marketing start 2012-05-29
Marketing end 0000-00-00
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 40 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 72 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077575-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 A077575-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 A077575-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 A077575-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29
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 · 176 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 2026-10-15 13:18:30 2026-09 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077575-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077575-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077575-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077575-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2012-05-29 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATORVASTATIN CALCIUM TRIHYDRATE ACTIVE INGREDIENT 48A5M73Z4Q ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V ATORVASTATIN CALCIUM TABLET, FILM COATED [SANDOZ INC] 6
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-5384-92 00781538492 90 TABLET, FILM COATED in 1 BOTTLE (0781-5384-92) 2012-05-29 0000-00-00 No No Current