Home NDC 42385-940 Atorvastatin Calcium
Product NDC 42385-940
11-digit product format 423850940
Labeler code 42385
Product ID 42385-940_ba8208d7-c3b8-4ddc-8826-9f5265513bfa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Laurus Labs Limited
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 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 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 · 68 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 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214513-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214513-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214513-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214513-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-01-22 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atorvastatin Calcium
Listing expiration 2026-12-31 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 · 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 42385-940-01 Atorvastatin Calcium 100 in 1 BOTTLE TABLET, FILM COATED 100 2 42385-940-05 Atorvastatin Calcium 500 in 1 BOTTLE TABLET, FILM COATED 500 2 42385-940-10 Atorvastatin Calcium 10 in 1 BLISTER PACK TABLET, FILM COATED 10 2 42385-940-11 Atorvastatin Calcium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 42385-940-30 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 2 42385-940-68 Atorvastatin Calcium 10 in 1 CARTON TABLET, FILM COATED 10 2 42385-940-90 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-940 ATORVASTATIN CALCIUM TABLET, FILM COATED [LAURUS LABS LIMITED] 1 Current NDC, 7 package rows 20240208_9f8ca507-b784-4d18-8d3e-d7d68072c416.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 1 of 1 · 2 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 42385-940-01 42385094001 100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01) 2024-01-23 No No Current 42385-940-05 42385094005 500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05) 2024-01-23 No No Current 42385-940-10 42385094010 10 in 1 BLISTER PACK Historical 42385-940-11 42385094011 1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11) 2024-01-23 No No Current 42385-940-30 42385094030 30 TABLET, FILM COATED in 1 BOTTLE (42385-940-30) 2024-01-23 No No Current 42385-940-68 42385094068 10 BLISTER PACK in 1 CARTON (42385-940-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-940-10) 10 blister pack 2024-01-23 No No Current 42385-940-90 42385094090 90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90) 2024-01-23 No No Current