Home NDC 68462-841 Telmisartan and Hydrochlorothiazide
Product NDC 68462-841
11-digit product format 684620841
Labeler code 68462
Product ID 68462-841_697f1231-2483-4e0b-9e23-aeb576fa6171
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA202544
Marketing category ANDA
Marketing start 2019-03-04
Substance TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength 80; 12.5 mg/1; mg/1
Pharmacologic classes Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [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 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET / ORAL AB 2019-03-04 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET / ORAL AB 2019-03-04 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET / ORAL AB 2019-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 132 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 2026-10-15 13:18:30 2026-09 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 c2088c7a36db…2026-09-14 22:38:34 2026-08 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202544-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2019-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202544-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2019-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202544-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2019-03-04 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 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 Hydrochlorothiazide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TELMISARTAN 80 mg/1 HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup U5SYW473RQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283316 Internal RxNorm lookup 283317 Internal RxNorm lookup 477130 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 68462-841-13 Telmisartan and Hydrochlorothiazide 3 in 1 CARTON TABLET 3 5 68462-841-13 Telmisartan and Hydrochlorothiazide 10 in 1 BLISTER PACK TABLET 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-841 TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 Current NDC, Legacy NDC, 2 package rows 20240312_1e55800d-f77c-4950-a6d7-2055f4c7ea17.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 · 2 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 68462-841-13 68462084113 3 BLISTER PACK in 1 CARTON (68462-841-13) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2019-03-04 0000-00-00 No No Current