Home NDC 58151-157 Lipitor
Product NDC 58151-157
11-digit product format 581510157
Labeler code 58151
Product ID 58151-157_dd011a82-7356-4b83-86c4-b21cd9138fc6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atorvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020702
Marketing category NDA
Marketing start 2024-01-03
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 2027-12-31
Current FDA listing Yes 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 N020702-001 LIPITOR ATORVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-002 LIPITOR ATORVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-003 LIPITOR ATORVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 N020702-004 LIPITOR ATORVASTATIN CALCIUM EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07
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 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-001 LIPITOR EQ 10MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-002 LIPITOR EQ 20MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-003 LIPITOR EQ 40MG BASE TABLET / ORAL AB RLD 1996-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020702-004 LIPITOR EQ 80MG BASE TABLET / ORAL AB RLD, RS 2000-04-07 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Observed Orange Book exclusivity history# 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 Lipitor
Listing expiration 2027-12-31 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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259255 Internal RxNorm lookup 262095 Internal RxNorm lookup 617310 Internal RxNorm lookup 617311 Internal RxNorm lookup 617312 Internal RxNorm lookup 617314 Internal RxNorm lookup 617318 Internal RxNorm lookup 617320 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 58151-157-77 Lipitor 90 in 1 BOTTLE TABLET, FILM COATED 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-157 LIPITOR (ATORVASTATIN CALCIUM) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] 7 Current NDC, 1 package rows 20240627_a60cc18b-0631-4cf0-b021-9f52224ece65.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 Marketing start Sample Exclude flag Status 58151-157-77 58151015777 90 TABLET, FILM COATED in 1 BOTTLE (58151-157-77) 2024-01-03 No No Current