Home NDC 68382-424 Amlodipine and atorvastatin
Product NDC 68382-424
11-digit product format 683820424
Labeler code 68382
Product ID 68382-424_63951023-2bfe-4973-87f2-07b3f5a010fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and atorvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA207762
Marketing category ANDA
Marketing start 2019-05-30
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 2021-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A207762-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 A207762-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 A207762-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 A207762-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 A207762-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 A207762-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 A207762-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 A207762-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 A207762-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 A207762-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 A207762-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 11 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 A207762-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207762-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207762-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207762-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207762-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207762-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207762-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2019-01-11 31067a03dcf5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 11 · 429 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-424-01 68382042401 100 TABLET, FILM COATED in 1 BOTTLE (68382-424-01) 2019-05-30 0000-00-00 No No Current 68382-424-06 68382042406 30 TABLET, FILM COATED in 1 BOTTLE (68382-424-06) 2019-05-30 0000-00-00 No No Current 68382-424-16 68382042416 90 TABLET, FILM COATED in 1 BOTTLE (68382-424-16) 2019-05-30 0000-00-00 No No Current 68382-424-77 68382042477 10 BLISTER PACK in 1 CARTON (68382-424-77) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-424-30) 10 blister pack 2019-05-30 0000-00-00 No No Current