Home NDC 55111-121-05 Atorvastatin Calcium
Product NDC 55111-121
Requested package NDC 55111-121-05
11-digit product format 551110121
Labeler code 55111
Product ID 55111-121_36e09eff-3948-2638-b633-d5ec2bc03d2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA091650
Marketing category ANDA
Marketing start 2012-07-17
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091650-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 A091650-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 A091650-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 123 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 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091650-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2012-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091650-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2012-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091650-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2012-07-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 55111-121-05 Atorvastatin Calcium 500 in 1 BOTTLE TABLET 500 24 55111-121-10 Atorvastatin Calcium 1000 in 1 BOTTLE TABLET 1000 24 55111-121-30 Atorvastatin Calcium 30 in 1 BOTTLE TABLET 30 24 55111-121-60 Atorvastatin Calcium 60 in 1 BOTTLE TABLET 60 24 55111-121-90 Atorvastatin Calcium 90 in 1 BOTTLE TABLET 90 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Atorvastatin Calcium ACTIVE INGREDIENT 48A5M73Z4Q ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 atorvastatin ACTIVE MOIETY A0JWA85V8F ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 crospovidone INACTIVE INGREDIENT 68401960MK ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 Hydroxypropyl Cellulose (Type H) INACTIVE INGREDIENT RFW2ET671P ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 methyl alcohol INACTIVE INGREDIENT Y4S76JWI15 ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 methylene chloride INACTIVE INGREDIENT 588X2YUY0A ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 sodium bicarbonate INACTIVE INGREDIENT 8MDF5V39QO ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 11 ATORVASTATIN CALCIUM TRIHYDRATE ACTIVE INGREDIENT 48A5M73Z4Q ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ATORVASTATIN ACTIVE MOIETY A0JWA85V8F ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 CROSPOVIDONE (15 MPA.S AT 5%) INACTIVE INGREDIENT 68401960MK ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 905HNO1SIH ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 METHYLENE CHLORIDE INACTIVE INGREDIENT 588X2YUY0A ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATORVASTATIN CALCIUM TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-121 ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 24 Current NDC, Legacy NDC, 5 package rows 20210925_901550e6-22be-68c9-eb86-f85a9c9dd998.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-121-05 55111012105 500 TABLET in 1 BOTTLE (55111-121-05) 500 tablet 2012-07-17 0000-00-00 No No Current