Home NDC 0378-4511 Amlodipine and atorvastatin
Product NDC 0378-4511
11-digit product format 003784511
Labeler code 0378
Product ID 0378-4511_bd2370c0-0e67-4e93-b4cf-08134ba68346
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and atorvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA200465
Marketing category ANDA
Marketing start 2014-06-19
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 3 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-4511-93 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0378-4511-93 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-4511-93 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-4511-93 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-4511-93 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-4511-93 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0378-4511-93 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-4511-93 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-4511-93 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0378-4511-93 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0378-4511-93 367a005e9d99…383a685ebd0f…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 0378-4511-93 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 11 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200465-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL 2013-11-29 A200465-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL 2013-11-29 A200465-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL 2013-11-29 A200465-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 A200465-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 A200465-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 A200465-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 A200465-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 A200465-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 A200465-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 A200465-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 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 12 · 473 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 A200465-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200465-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200465-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200465-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200465-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200465-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2013-11-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200465-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2013-11-29 31067a03dcf5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 10 · 368 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0378-4511-93 00378451193 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4511-93) 2014-06-19 0000-00-00 No No Current