Home NDC 33342-191 AMLODIPINE and OLMESARTAN medoxomil
Product NDC 33342-191
11-digit product format 333420191
Labeler code 33342
Product ID 33342-191_bd687a21-be18-439a-8e65-103a15b4a8f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMLODIPINE and OLMESARTAN medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA206884
Marketing category ANDA
Marketing start 2016-10-27
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 5; 40 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26
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 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206884-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206884-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206884-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206884-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2016-10-26 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 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 OLMESARTAN medoxomil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMLODIPINE BESYLATE 5 mg/1 OLMESARTAN MEDOXOMIL 40 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 6M97XTV3HD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 730861 Internal RxNorm lookup 730866 Internal RxNorm lookup 730869 Internal RxNorm lookup 730872 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 33342-191-07 AMLODIPINE and OLMESARTAN medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 6 33342-191-10 AMLODIPINE and OLMESARTAN medoxomil 90 in 1 BOTTLE TABLET, FILM COATED 90 6 33342-191-12 AMLODIPINE and OLMESARTAN medoxomil 10 in 1 BLISTER PACK TABLET, FILM COATED 10 6 33342-191-12 AMLODIPINE and OLMESARTAN medoxomil 10 in 1 CARTON TABLET, FILM COATED 10 6 33342-191-44 AMLODIPINE and OLMESARTAN medoxomil 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-191 AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 5 Current NDC, Legacy NDC, 5 package rows 20221214_c86a3c45-c906-46c9-9f7b-6c3d89bbe48f.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 Units Marketing start Marketing end Sample Exclude flag Status 33342-191-07 33342019107 30 TABLET, FILM COATED in 1 BOTTLE (33342-191-07) 2016-10-27 0000-00-00 No No Current 33342-191-10 33342019110 90 TABLET, FILM COATED in 1 BOTTLE (33342-191-10) 2016-10-27 0000-00-00 No No Current 33342-191-12 33342019112 10 BLISTER PACK in 1 CARTON (33342-191-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2016-10-27 0000-00-00 No No Current 33342-191-44 33342019144 1000 TABLET, FILM COATED in 1 BOTTLE (33342-191-44) 2016-10-27 0000-00-00 No No Current