Home NDC 42291-796-30 Telmisartan and Amlodipine
Product NDC 42291-796
Requested package NDC 42291-796-30
11-digit product format 422910796
Labeler code 42291
Product ID 42291-796_d5c9e15b-7e82-d9a5-e053-2995a90a9725
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan and Amlodipine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA201586
Marketing category ANDA
Marketing start 2017-08-09
Marketing end 0000-00-00
Substance AMLODIPINE BESYLATE; TELMISARTAN
Active strength 10 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A201586-001 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET / ORAL 2014-01-08 A201586-002 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET / ORAL 2014-01-08 A201586-003 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET / ORAL 2014-01-08 A201586-004 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET / ORAL 2014-01-08
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 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL 2014-01-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL 2014-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL 2014-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201586-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201586-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201586-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201586-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB 2014-01-08 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-796-30 42291079630 30 TABLET in 1 BOTTLE (42291-796-30) 30 tablet 2017-08-09 0000-00-00 No No Current