Home NDC 42708-005-30 Atorvastatin Calcium
Product NDC 42708-005
Requested package NDC 42708-005-30
11-digit product format 427080005
Labeler code 42708
Product ID 42708-005_45b41a94-e930-c847-e063-6394a90ad348
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler QPharma, Inc.
Application ANDA205300
Marketing category ANDA
Marketing start 2017-05-04
Substance ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 40 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 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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATORVASTATIN CALCIUM TRIHYDRATE 40 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42708-005-30 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42708-005 ATORVASTATIN CALCIUM TABLET, FILM COATED [QPHARMA, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20241128_3e59aa97-5480-41e0-86b0-047e648b976d.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 42708-005-30 42708000530 30 TABLET, FILM COATED in 1 BOTTLE (42708-005-30) 2018-05-31 0000-00-00 Yes No Current