Home NDC 0093-5056 Atorvastatin Calcium
Product NDC 0093-5056
11-digit product format 000935056
Labeler code 0093
Product ID 0093-5056_5a4bae3d-a27b-4319-9450-36fdaf57d1e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA205300
Marketing category ANDA
Marketing start 2017-05-04
Marketing end 2027-12-31
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 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 A205300-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 A205300-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 A205300-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 A205300-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27
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 5 · 164 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 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205300-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205300-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205300-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-03-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205300-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2017-03-27 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atorvastatin Calcium 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 0093-5056-10 Atorvastatin Calcium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 16 0093-5056-98 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5056 ATORVASTATIN CALCIUM TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20240622_86841382-4229-4e03-958e-3ac22639efd4.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 Marketing end Sample Exclude flag Status 0093-5056-10 00093505610 1000 TABLET, FILM COATED in 1 BOTTLE (0093-5056-10) 2022-05-23 0000-00-00 No No Current 0093-5056-98 00093505698 90 TABLET, FILM COATED in 1 BOTTLE (0093-5056-98) 2017-05-04 0000-00-00 No No Current