Home NDC 45865-935-30 Amlodipine and Olmesartan Medoxomil
Product NDC 45865-935
Requested package NDC 45865-935-30
11-digit product format 458650935
Labeler code 45865
Product ID 45865-935_7df356fc-4477-2d5a-e053-2991aa0a4a16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amlodipine and Olmesartan Medoxomil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler medsource pharmaceuticals
Application ANDA207807
Marketing category ANDA
Marketing start 2017-08-15
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength 5 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 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 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05
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 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL 2017-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL 2017-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL 2017-07-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL 2017-07-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207807-001 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;20MG TABLET / ORAL AB 2017-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207807-002 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 5MG BASE;40MG TABLET / ORAL AB 2017-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207807-003 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;20MG TABLET / ORAL AB 2017-07-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207807-004 AMLODIPINE AND OLMESARTAN MEDOXOMIL EQ 10MG BASE;40MG TABLET / ORAL AB 2017-07-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 124 observed states.
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 45865-935-30 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 45865-935 AMLODIPINE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 1 package rows 20181227_7df354bd-d4fc-2807-e053-2991aa0ae587.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 Marketing start Marketing end Sample Exclude flag Status 45865-935-30 45865093530 30 TABLET, FILM COATED in 1 BOTTLE (45865-935-30) 2018-06-01 0000-00-00 No No Current