Home NDC 45865-901 Amlodipine and Olmesartan Medoxomil
Product NDC 45865-901
11-digit product format 458650901
Labeler code 45865
Product ID 45865-901_7d641e3c-5d84-dd95-e053-2991aa0a9423
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler medsource pharmaceuticals
Application ANDA091154
Marketing category ANDA
Marketing start 2016-10-26
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 10 mg/1; mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45865-901-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45865-901-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45865-901-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45865-901-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45865-901-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45865-901-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45865-901-30 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45865-901-30 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45865-901-30 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26
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 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091154-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091154-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091154-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2016-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091154-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2016-10-26 5bbf6a4d5a75…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45865-901-30 Amlodipine and Olmesartan Medoxomil 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-901 AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 1 package rows 20181220_7d641e3c-5d83-dd95-e053-2991aa0a9423.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 45865-901-30 45865090130 30 TABLET, FILM COATED in 1 BOTTLE (45865-901-30) 2018-06-01 0000-00-00 No No Current