Home NDC 0378-1078 Telmisartan and Amlodipine
Product NDC 0378-1078
11-digit product format 003781078
Labeler code 0378
Product ID 0378-1078_c4f4323d-671d-478b-b088-008530932cee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name telmisartan and amlodipine
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA202516
Marketing category ANDA
Marketing start 2014-09-19
Substance TELMISARTAN; AMLODIPINE BESYLATE
Active strength 80; 10 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 A202516-001 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG TABLET / ORAL 2014-08-26 A202516-002 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG TABLET / ORAL 2014-08-26 A202516-003 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG TABLET / ORAL 2014-08-26 A202516-004 TELMISARTAN AND AMLODIPINE AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG TABLET / ORAL RS 2014-08-26
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 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-08-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL RS 2014-08-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL RS 2014-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL 2014-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL 2014-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL 2014-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL 2014-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202516-001 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;40MG TABLET / ORAL AB 2014-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202516-002 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;40MG TABLET / ORAL AB 2014-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202516-003 TELMISARTAN AND AMLODIPINE EQ 5MG BASE;80MG TABLET / ORAL AB 2014-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202516-004 TELMISARTAN AND AMLODIPINE EQ 10MG BASE;80MG TABLET / ORAL AB RS 2014-08-26 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.
Additional Listing Data#
Finished product Yes
Brand name base Telmisartan and Amlodipine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TELMISARTAN 80 mg/1 AMLODIPINE BESYLATE 10 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 U5SYW473RQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 876514 Internal RxNorm lookup 876519 Internal RxNorm lookup 876524 Internal RxNorm lookup 876529 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 0378-1078-93 Telmisartan and Amlodipine 30 in 1 BOTTLE, PLASTIC TABLET 30 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-1078 TELMISARTAN AND AMLODIPINE TABLET [MYLAN PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240711_ca60a4d5-ace7-4889-94ee-e2265fd63811.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 0378-1078-93 00378107893 30 TABLET in 1 BOTTLE, PLASTIC (0378-1078-93) 30 tablet 2014-09-19 0000-00-00 No No Current