Home NDC 68071-5008 Atorvastatin Calcium
Product NDC 68071-5008
11-digit product format 680715008
Labeler code 68071
Product ID 68071-5008_1b30e987-a59c-7625-e063-6394a90a3de2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atorvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA209288
Marketing category ANDA
Marketing start 2018-12-23
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 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 · 8 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68071-5008-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-5008-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-5008-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-5008-3 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A209288-001 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 A209288-002 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 A209288-003 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 A209288-004 ATORVASTATIN CALCIUM ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21
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 · 172 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 2026-09-14 22:38:34 2026-08 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-001 ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-002 ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-003 ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209288-004 ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB 2018-12-21 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68071-5008-3 Atorvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5008 ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240816_8ee8b455-625c-ead6-e053-2a95a90aed29.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 2 of 2 · 21 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 68071-5008-3 68071500803 30 TABLET, FILM COATED in 1 BOTTLE (68071-5008-3) 2019-07-30 0000-00-00 No No Current