Home NDC 68180-198-06 Telmisartan and Amlodipine
Product NDC 68180-198
Requested package NDC 68180-198-06
11-digit product format 681800198
Labeler code 68180
Product ID 68180-198_db056024-a5b4-4f2a-8fe0-8ee308cf5700
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan and Amlodipine
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201586
Marketing category ANDA
Marketing start 2014-01-08
Marketing end 0000-00-00
Substance TELMISARTAN; AMLODIPINE BESYLATE
Active strength 80 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 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 · 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-198-06 Telmisartan and Amlodipine 30 in 1 BOTTLE TABLET 30 10 68180-198-09 Telmisartan and Amlodipine 90 in 1 BOTTLE TABLET 90 10 68180-198-12 Telmisartan and Amlodipine 10 in 1 BLISTER PACK TABLET 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 TELMISARTAN ACTIVE INGREDIENT U5SYW473RQ TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 AMLODIPINE ACTIVE MOIETY 1J444QC288 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 TELMISARTAN ACTIVE MOIETY U5SYW473RQ TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-198 TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.] 10 Legacy NDC, 3 package rows 20231216_a97fefa6-99e6-4eb7-9393-ab2252a2c7d8.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 68180-198-06 68180019806 30 TABLET in 1 BOTTLE (68180-198-06) 30 tablet 2014-01-08 0000-00-00 No No Current