Home NDC 62332-209-10 Telmisartan and Hydrochlorothiazide
Product NDC 62332-209
Requested package NDC 62332-209-10
11-digit product format 623320209
Labeler code 62332
Product ID 62332-209_bd39fc6f-f337-44fe-9192-091d45a40750
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Telmisartan and Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA203010
Marketing category ANDA
Marketing start 2016-06-25
Substance TELMISARTAN; HYDROCHLOROTHIAZIDE
Active strength 40; 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 45 .
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 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;40MG TABLET / ORAL AB 2014-02-25 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 12.5MG;80MG TABLET / ORAL AB 2014-02-25 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TELMISARTAN 25MG;80MG TABLET / ORAL AB 2014-02-25
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 · 135 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 2026-11-14 07:37:17 2026-10 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203010-002 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;80MG TABLET / ORAL AB 2014-02-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203010-003 TELMISARTAN AND HYDROCHLOROTHIAZIDE 25MG;80MG TABLET / ORAL AB 2014-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203010-001 TELMISARTAN AND HYDROCHLOROTHIAZIDE 12.5MG;40MG TABLET / ORAL AB 2014-02-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 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 40 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 U5SYW473RQ Internal UNII lookup 0J48LPH2TH 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 62332-209-10 Telmisartan and Hydrochlorothiazide 100 in 1 CARTON TABLET 100 11 62332-209-30 Telmisartan and Hydrochlorothiazide 30 in 1 BOTTLE TABLET 30 11 62332-209-91 Telmisartan and Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-209 TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 3 package rows 20230921_e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7.zip
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 62332-209-10 62332020910 100 TABLET in 1 CARTON (62332-209-10) 100 tablet 2016-06-25 0000-00-00 No No Current