Home NDC 71335-3144 Atorvastatin Calcium
Product NDC 71335-3144
11-digit product format 713353144
Labeler code 71335
Product ID 71335-3144_74aad35e-d559-4a14-a43c-76d757f37867
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA214513
Marketing category ANDA
Marketing start 2024-01-23
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 2027-12-31
Current FDA listing Yes 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 A214513-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 A214513-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 A214513-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 A214513-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22
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 2 · 76 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 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atorvastatin Calcium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATORVASTATIN CALCIUM TRIHYDRATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 48A5M73Z4Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617312 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71335-3144-1 71335314401 30 TABLET, FILM COATED in 1 BOTTLE (71335-3144-1) 2026-06-18 No No Current 71335-3144-2 71335314402 90 TABLET, FILM COATED in 1 BOTTLE (71335-3144-2) 2026-06-18 No No Current 71335-3144-3 71335314403 60 TABLET, FILM COATED in 1 BOTTLE (71335-3144-3) 2026-06-18 No No Current 71335-3144-4 71335314404 120 TABLET, FILM COATED in 1 BOTTLE (71335-3144-4) 2026-06-18 No No Current 71335-3144-5 71335314405 100 TABLET, FILM COATED in 1 BOTTLE (71335-3144-5) 2026-06-18 No No Current 71335-3144-6 71335314406 180 TABLET, FILM COATED in 1 BOTTLE (71335-3144-6) 2026-06-18 No No Current