Home NDC 60760-905 Atorvastatin Calcium
Product NDC 60760-905
11-digit product format 607600905
Labeler code 60760
Product ID 60760-905_ded422c3-1287-479e-e053-2a95a90aefc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA091624
Marketing category ANDA
Marketing start 2017-12-15
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 2023-12-31
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 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A091624-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 A091624-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 A091624-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 A091624-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05
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 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091624-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2013-04-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60760-905-30 60760090530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-905-30) 2017-12-15 0000-00-00 No No Current 60760-905-90 60760090590 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-905-90) 2017-12-15 0000-00-00 No No Current