Telmisartan and Hydrochlorothiazide

Product NDC
62332-209
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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;40MGTABLET / ORALAB2014-02-25
A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN12.5MG;80MGTABLET / ORALAB2014-02-25
A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TELMISARTAN25MG;80MGTABLET / ORALAB2014-02-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A203010-001AB
A203010-002AB
A203010-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25c2088c7a36db…
2026-10-15 13:18:302026-09A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25c2088c7a36db…
2026-10-15 13:18:302026-09A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25c2088c7a36db…
2026-09-14 22:38:342026-08A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-2584e616aacf4f…
2026-09-14 22:38:342026-08A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25caaa826d4ba7…
2026-08-18 06:07:402026-07A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203010-002TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2014-02-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203010-003TELMISARTAN AND HYDROCHLOROTHIAZIDE25MG;80MGTABLET / ORALAB2014-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203010-001TELMISARTAN AND HYDROCHLOROTHIAZIDE12.5MG;40MGTABLET / ORALAB2014-02-2579d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A203010-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203010-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A203010-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A203010-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203010-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A203010-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A203010-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203010-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203010-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203010-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203010-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203010-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203010-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203010-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203010-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203010-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203010-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203010-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203010-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203010-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203010-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203010-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203010-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203010-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203010-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203010-001AB179d66fd596c7…

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
IngredientStrength
TELMISARTAN40 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J48LPH2THInternal UNII lookup
U5SYW473RQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283316Internal RxNorm lookup
283317Internal RxNorm lookup
477130Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
796916df-49fa-d043-64a7-fee11194676cProduct name920171130
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-209-10Telmisartan and Hydrochlorothiazide100 in 1 CARTONTABLET10011
62332-209-30Telmisartan and Hydrochlorothiazide30 in 1 BOTTLETABLET3011
62332-209-91Telmisartan and Hydrochlorothiazide1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-209-30EA - Each62332-2091fdfed20-1ecf-4ea6-a4de-0f708403326812016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-209TELMISARTAN AND HYDROCHLOROTHIAZIDE TABLET [ALEMBIC PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 3 package rows20230921_e80f232c-c1c4-4524-a0a5-d23ee0d1f3b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283316telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
283317telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
477130telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
283316hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral TabletSCDe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
283317hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral TabletSCDe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
477130hydrochlorothiazide 25 MG / telmisartan 80 MG Oral TabletSCDe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
283316HCTZ 12.5 MG / telmisartan 40 MG Oral TabletSYe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
283317HCTZ 12.5 MG / telmisartan 80 MG Oral TabletSYe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711
477130HCTZ 25 MG / telmisartan 80 MG Oral TabletSYe80f232c-c1c4-4524-a0a5-d23ee0d1f3b711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-209-1062332020910100 TABLET in 1 CARTON (62332-209-10) 100 tablet2016-06-250000-00-00NoNoCurrent
62332-209-306233202093030 TABLET in 1 BOTTLE (62332-209-30) 30 tablet2016-06-250000-00-00NoNoCurrent
62332-209-91623320209911000 TABLET in 1 BOTTLE (62332-209-91) 1000 tablet2016-06-250000-00-00NoNoCurrent