Home NDC 0480-3588 Atorvastatin Calcium
Product NDC 0480-3588
11-digit product format 004803588
Labeler code 0480
Product ID 0480-3588_6c4083f7-0712-4028-8c8a-5cc7b086ecdf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA220276
Marketing category ANDA
Marketing start 2026-05-08
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 80 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 A220276-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2025-11-13 A220276-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2025-11-13 A220276-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2025-11-13 A220276-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2025-11-13
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.
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 A220276-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220276-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220276-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2025-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A220276-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2025-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220276-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220276-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220276-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2025-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A220276-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2025-11-13 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220276-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220276-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220276-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2025-11-13 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220276-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2025-11-13 a50c72e98297…
Observed Orange Book normalized TE history# 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 80 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 0480-3588-10 Atorvastatin Calcium 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 0480-3588-98 Atorvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 2
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 Marketing start Sample Exclude flag Status 0480-3588-10 00480358810 1000 TABLET, FILM COATED in 1 BOTTLE (0480-3588-10) 2026-05-08 No No Current 0480-3588-98 00480358898 90 TABLET, FILM COATED in 1 BOTTLE (0480-3588-98) 2026-05-20 No No Current