Home NDC 68788-7900 Atorvastatin Calcium
Product NDC 68788-7900
11-digit product format 687887900
Labeler code 68788
Product ID 68788-7900_75445b2c-6a22-46d2-81fd-e89f2544aab8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application ANDA209288
Marketing category ANDA
Marketing start 2021-05-14
Marketing end 0000-00-00
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 10 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
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 A209288-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 A209288-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 A209288-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 A209288-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21
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 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 c2088c7a36db…2026-10-15 13:18:30 2026-09 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 c2088c7a36db…2026-09-14 22:38:34 2026-08 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7900 ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] 5 Legacy NDC 20250206_7fc504dd-718a-4340-825f-e19ed76b71ef.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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7900-1 68788790001 100 TABLET, FILM COATED in 1 BOTTLE (68788-7900-1) 2021-05-14 0000-00-00 No No Current 68788-7900-3 68788790003 30 TABLET, FILM COATED in 1 BOTTLE (68788-7900-3) 2021-05-14 0000-00-00 No No Current 68788-7900-6 68788790006 60 TABLET, FILM COATED in 1 BOTTLE (68788-7900-6) 2021-05-14 0000-00-00 No No Current 68788-7900-9 68788790009 90 TABLET, FILM COATED in 1 BOTTLE (68788-7900-9) 2021-05-14 0000-00-00 No No Current