Home NDC 59651-606 Atorvastatin Calcium
Product NDC 59651-606
11-digit product format 596510606
Labeler code 59651
Product ID 59651-606_b9128b7d-1e45-4f05-9f0a-26bd825e402d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA217118
Marketing category ANDA
Marketing start 2024-02-13
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 59651-606 UNFINISHED Active or certified unfinished drug listing 2026-08-07 unfinished package package 59651-606 59651-606-12 UNFINISHED Active or certified unfinished drug listing 2026-08-07
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 59651-606-12 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 59651-606-12 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 59651-606-12 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 59651-606-12 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 59651-606-12 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 59651-606-12 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 59651-606-12 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 59651-606-12 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 59651-606-12 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 59651-606-12 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 59651-606-12 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 59651-606-12 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 59651-606-12 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 59651-606-12 50b4072663b7…eae3003ed65e…
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 A217118-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 A217118-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 A217118-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 A217118-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13
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 · 64 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 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217118-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217118-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217118-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217118-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2024-02-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 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 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 59651-606-05 Atorvastatin Calcium 500 in 1 BOTTLE TABLET, FILM COATED 500 3 59651-606-30 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 3 59651-606-90 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 3 59651-606-99 Atorvastatin Calcium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-606 ATORVASTATIN CALCIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, 4 package rows 20240426_536b5e0d-1bb9-4c9d-a588-460d7647308b.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-606-05 59651060605 500 TABLET, FILM COATED in 1 BOTTLE (59651-606-05) 2024-02-13 No No Current 59651-606-12 59651060612 120000 TABLET, FILM COATED in 1 BAG (59651-606-12) 13-FEB-24 Current 59651-606-30 59651060630 30 TABLET, FILM COATED in 1 BOTTLE (59651-606-30) 2024-02-13 No No Current 59651-606-90 59651060690 90 TABLET, FILM COATED in 1 BOTTLE (59651-606-90) 2024-02-13 No No Current 59651-606-99 59651060699 1000 TABLET, FILM COATED in 1 BOTTLE (59651-606-99) 2024-02-13 No No Current