Home NDC 33342-317 Atorvastatin calcium
Product NDC 33342-317
11-digit product format 333420317
Labeler code 33342
Product ID 33342-317_7bd0f0ec-f7a3-4403-9a1a-11f18213631f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin calcium
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA208480
Marketing category ANDA
Marketing start 2024-06-03
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A208480-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 A208480-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 A208480-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 A208480-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03
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 · 56 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 2026-02-19 14:30 UTC 2026-02 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208480-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208480-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208480-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-06-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208480-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-06-03 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 56 observed states.
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 40 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259255 Internal RxNorm lookup 617310 Internal RxNorm lookup 617311 Internal RxNorm lookup 617312 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 33342-317-10 Atorvastatin calcium 90 in 1 BOTTLE TABLET 90 1 33342-317-12 Atorvastatin calcium 10 in 1 BLISTER PACK TABLET 10 1 33342-317-12 Atorvastatin calcium 10 in 1 CARTON TABLET 10 1 33342-317-15 Atorvastatin calcium 500 in 1 BOTTLE TABLET 500 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-317-10 33342031710 90 TABLET in 1 BOTTLE (33342-317-10) 90 tablet 2024-06-03 No No Current 33342-317-11 33342031711 100 TABLET in 1 BOTTLE (33342-317-11) 100 tablet 2026-05-21 0 Current 33342-317-12 33342031712 10 BLISTER PACK in 1 CARTON (33342-317-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2024-06-03 No No Current 33342-317-15 33342031715 500 TABLET in 1 BOTTLE (33342-317-15) 500 tablet 2024-06-03 No No Current 33342-317-44 33342031744 1000 TABLET in 1 BOTTLE (33342-317-44) 1000 tablet 2026-05-27 0 Current