FDA.reportPublic FDA data

Micardis HCT

Product NDC
0597-0043
11-digit product format
005970043
Labeler code
0597
Product ID
0597-0043_ea1ff12a-df9e-477b-9e91-f89381987c6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
telmisartan and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA021162
Marketing category
NDA
Marketing start
2000-12-01
Substance
HYDROCHLOROTHIAZIDE; TELMISARTAN
Active strength
12.5; 40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Micardis HCT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
TELMISARTAN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, U5SYW473RQ
Rxcui283316, 283317, 477130, 749833, 749837, 749841

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
0597-0043-37Micardis HCT3 in 1 CARTONTABLET326
0597-0043-37Micardis HCT10 in 1 BLISTER PACKTABLET1026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0043-37EA - Each0597-00432e2d41c2-accc-4ca9-a9d2-41df7342656f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]17
TELMISARTANACTIVE INGREDIENTU5SYW473RQMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]17
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]17
TELMISARTANACTIVE MOIETYU5SYW473RQMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]17
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TELMISARTANACTIVE INGREDIENTU5SYW473RQMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
TELMISARTANACTIVE MOIETYU5SYW473RQMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0043MICARDIS HCT (TELMISARTAN AND HYDROCHLOROTHIAZIDE) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 2 package rows20250327_b078dae2-664d-4144-847a-3b9d9b557402.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749833Micardis HCT 40 MG /12.5 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
749837Micardis-HCT 80 MG / 12.5 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
749841Micardis-HCT 80 MG / 25 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
283316telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
283317telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
477130telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb078dae2-664d-4144-847a-3b9d9b55740226
749833hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]SBDb078dae2-664d-4144-847a-3b9d9b55740226
749837hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SBDb078dae2-664d-4144-847a-3b9d9b55740226
749841hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SBDb078dae2-664d-4144-847a-3b9d9b55740226
283316hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral TabletSCDb078dae2-664d-4144-847a-3b9d9b55740226
283317hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral TabletSCDb078dae2-664d-4144-847a-3b9d9b55740226
477130hydrochlorothiazide 25 MG / telmisartan 80 MG Oral TabletSCDb078dae2-664d-4144-847a-3b9d9b55740226
283316HCTZ 12.5 MG / telmisartan 40 MG Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749833HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]SYb078dae2-664d-4144-847a-3b9d9b55740226
283317HCTZ 12.5 MG / telmisartan 80 MG Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749837HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SYb078dae2-664d-4144-847a-3b9d9b55740226
477130HCTZ 25 MG / telmisartan 80 MG Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749841HCTZ 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SYb078dae2-664d-4144-847a-3b9d9b55740226
749833Micardis-HCT 40/12.5 (telmisartan / hydrochlorothiazide) Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749833Micardis-HCT 40/12.5 Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749837Micardis-HCT 80/12.5 (telmisartan / hydrochlorothiazide) Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749837Micardis-HCT 80/12.5 Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749841Micardis-HCT 80/25 (telmisartan / hydrochlorothiazide) Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749841Micardis-HCT 80/25 Oral TabletSYb078dae2-664d-4144-847a-3b9d9b55740226
749833Micardis HCT 40 MG /12.5 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
749837Micardis-HCT 80 MG / 12.5 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
749841Micardis-HCT 80 MG / 25 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
283316telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
283317telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
477130telmisartan 80 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN539cdfb4-b920-48fb-8176-fe23841e3d322
749833hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]SBD539cdfb4-b920-48fb-8176-fe23841e3d322
749837hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SBD539cdfb4-b920-48fb-8176-fe23841e3d322
749841hydrochlorothiazide 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SBD539cdfb4-b920-48fb-8176-fe23841e3d322
283316hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral TabletSCD539cdfb4-b920-48fb-8176-fe23841e3d322
283317hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral TabletSCD539cdfb4-b920-48fb-8176-fe23841e3d322
477130hydrochlorothiazide 25 MG / telmisartan 80 MG Oral TabletSCD539cdfb4-b920-48fb-8176-fe23841e3d322
283316HCTZ 12.5 MG / telmisartan 40 MG Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749833HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet [Micardis-HCT]SY539cdfb4-b920-48fb-8176-fe23841e3d322
283317HCTZ 12.5 MG / telmisartan 80 MG Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749837HCTZ 12.5 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SY539cdfb4-b920-48fb-8176-fe23841e3d322
477130HCTZ 25 MG / telmisartan 80 MG Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749841HCTZ 25 MG / telmisartan 80 MG Oral Tablet [Micardis-HCT]SY539cdfb4-b920-48fb-8176-fe23841e3d322
749833Micardis-HCT 40/12.5 (telmisartan / hydrochlorothiazide) Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749833Micardis-HCT 40/12.5 Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749837Micardis-HCT 80/12.5 (telmisartan / hydrochlorothiazide) Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749837Micardis-HCT 80/12.5 Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749841Micardis-HCT 80/25 (telmisartan / hydrochlorothiazide) Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322
749841Micardis-HCT 80/25 Oral TabletSY539cdfb4-b920-48fb-8176-fe23841e3d322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0043-37005970043373 BLISTER PACK in 1 CARTON (0597-0043-37) / 10 TABLET in 1 BLISTER PACK3 blister pack2000-12-010000-00-00NoNoCurrent