Home NDC 62332-757 Amlodipine and Atorvastatin
Product NDC 62332-757
11-digit product format 623320757
Labeler code 62332
Product ID 62332-757_d7b14922-f4b8-4e3e-afdd-056aee8dc35b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Atorvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA217279
Marketing category ANDA
Marketing start 2025-05-23
Substance AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 2.5; 40 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A217279-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 A217279-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 A217279-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 A217279-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 A217279-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 A217279-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 A217279-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 A217279-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 A217279-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 A217279-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 A217279-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22
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 2 · 77 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 2026-10-15 13:18:30 2026-09 A217279-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A217279-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217279-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217279-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217279-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-008 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-009 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-010 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217279-011 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217279-001 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-002 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-003 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-004 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-005 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-006 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217279-007 AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB 2025-05-22 011fe1cb6892…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 77 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 Amlodipine and Atorvastatin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 2.5 mg/1 ATORVASTATIN CALCIUM TRIHYDRATE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 48A5M73Z4Q Internal UNII lookup 864V2Q084H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 11 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 404011 Internal RxNorm lookup 404013 Internal RxNorm lookup 597967 Internal RxNorm lookup 597971 Internal RxNorm lookup 597974 Internal RxNorm lookup 597977 Internal RxNorm lookup 597980 Internal RxNorm lookup 597984 Internal RxNorm lookup 597987 Internal RxNorm lookup 597990 Internal RxNorm lookup 597993 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 62332-757-30 Amlodipine and Atorvastatin 30 in 1 BOTTLE TABLET, FILM COATED 30 8 62332-757-90 Amlodipine and Atorvastatin 90 in 1 BOTTLE TABLET, FILM COATED 90 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-757 AMLODIPINE AND ATORVASTATIN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.] 8 Current NDC, 2 package rows 20250528_1346631f-e6db-4c5c-a6af-5aa7b80a011d.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 · 2 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 62332-757-30 62332075730 30 TABLET, FILM COATED in 1 BOTTLE (62332-757-30) 2025-05-23 No No Current 62332-757-90 62332075790 90 TABLET, FILM COATED in 1 BOTTLE (62332-757-90) 2025-05-23 No No Current