Home NDC 66993-271 Amlodipine and Atorvastatin
Product NDC 66993-271
11-digit product format 669930271
Labeler code 66993
Product ID 66993-271_c09c6dd4-0101-4551-878c-f28080948160
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Atorvastatin
Dosage form TABLET, COATED
Route ORAL
Labeler Prasco Laboratories
Application NDA021540
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-03-14
Substance AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE
Active strength 10; 20 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 1 .
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 N021540-001 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-002 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-003 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-004 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-005 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-006 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-007 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-01-30 N021540-008 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB RLD, RS 2004-01-30 N021540-009 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-07-29 N021540-010 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-07-29 N021540-011 CADUET AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-07-29
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.
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 2026-08-01 22:54:32 2026-06 N021540-001 CADUET EQ 5MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-002 CADUET EQ 5MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-003 CADUET EQ 5MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-004 CADUET EQ 5MG BASE;EQ 80MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-005 CADUET EQ 10MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-006 CADUET EQ 10MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-007 CADUET EQ 10MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-008 CADUET EQ 10MG BASE;EQ 80MG BASE TABLET / ORAL AB RLD, RS 2004-01-30 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-009 CADUET EQ 2.5MG BASE;EQ 10MG BASE TABLET / ORAL AB RLD 2004-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-010 CADUET EQ 2.5MG BASE;EQ 20MG BASE TABLET / ORAL AB RLD 2004-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N021540-011 CADUET EQ 2.5MG BASE;EQ 40MG BASE TABLET / ORAL AB RLD 2004-07-29 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 10 mg/1 ATORVASTATIN CALCIUM TRIHYDRATE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 864V2Q084H Internal UNII lookup 48A5M73Z4Q 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 66993-271-30 Amlodipine and Atorvastatin 30 in 1 BOTTLE TABLET, COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66993-271 AMLODIPINE AND ATORVASTATIN TABLET, COATED [PRASCO LABORATORIES] 10 Current NDC, Legacy NDC, 1 package rows 20250130_14124e56-77ba-426d-8f5a-dbe42eda1a20.zip
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 66993-271-30 66993027130 30 TABLET, COATED in 1 BOTTLE (66993-271-30) 2022-03-14 0000-00-00 No No Current