FDA.reportPublic FDA data

Triamterene and Hydrochlorothiazide

Product NDC
60505-2656
11-digit product format
605052656
Labeler code
60505
Product ID
60505-2656_2b178a53-cddb-a0e3-2eb7-752e47edc56a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA071251
Marketing category
ANDA
Marketing start
2009-09-21
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25; 37.5 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
TRIAMTERENE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, WS821Z52LQ
Rxcui310812, 310818

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
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
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
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
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
60505-2656-1Triamterene and Hydrochlorothiazide100 in 1 BOTTLETABLET10010
60505-2656-5Triamterene and Hydrochlorothiazide500 in 1 BOTTLETABLET50010
60505-2656-7Triamterene and Hydrochlorothiazide6500 in 1 BOTTLETABLET650010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2656-1EA - Each60505-26565c28cf4c-512f-45f9-ae8e-73dc5181263012012-07-24
60505-2656-5EA - Each60505-2656795b59e4-7e2e-4885-bdcd-64365ce7831e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2656TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [APOTEX CORP.]7Current NDC, Legacy NDC, 3 package rows20241004_bd6c3495-ec70-908b-482a-a979506659e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNec6dce85-5c0b-475c-af0b-cbbc034f698f103
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDec6dce85-5c0b-475c-af0b-cbbc034f698f103
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYec6dce85-5c0b-475c-af0b-cbbc034f698f103
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNf083c321-3170-4982-b5cd-d3fdff75485713
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDf083c321-3170-4982-b5cd-d3fdff75485713
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYf083c321-3170-4982-b5cd-d3fdff75485713
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNbd6c3495-ec70-908b-482a-a979506659e910
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSNbd6c3495-ec70-908b-482a-a979506659e910
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDbd6c3495-ec70-908b-482a-a979506659e910
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCDbd6c3495-ec70-908b-482a-a979506659e910
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYbd6c3495-ec70-908b-482a-a979506659e910
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSYbd6c3495-ec70-908b-482a-a979506659e910
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9fe534cd-cf5f-64b4-e053-2995a90a926e8
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD9fe534cd-cf5f-64b4-e053-2995a90a926e8
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY9fe534cd-cf5f-64b4-e053-2995a90a926e8
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNba764ce4-36fe-4aa4-96a4-d0479b875b4f7
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDba764ce4-36fe-4aa4-96a4-d0479b875b4f7
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYba764ce4-36fe-4aa4-96a4-d0479b875b4f7
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN90277796-e95a-4e0e-b1d4-784b920cc7bb4
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN25dc3437-0042-74a1-e054-00144ff88e884
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD25dc3437-0042-74a1-e054-00144ff88e884
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD90277796-e95a-4e0e-b1d4-784b920cc7bb4
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY25dc3437-0042-74a1-e054-00144ff88e884
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY90277796-e95a-4e0e-b1d4-784b920cc7bb4
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN9ec3d35f-b25d-48f4-926f-f093e402ccde3
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD9ec3d35f-b25d-48f4-926f-f093e402ccde3
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY9ec3d35f-b25d-48f4-926f-f093e402ccde3
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN88404726-423e-44be-a11e-67b5b014b0bc2
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD88404726-423e-44be-a11e-67b5b014b0bc2
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY88404726-423e-44be-a11e-67b5b014b0bc2
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb129e54a-a6d8-42c0-baac-e8db2487369b1
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNdbe8d4f6-c338-4076-9ae9-2e86c07672261
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN95827e99-91d8-3ba6-e053-2a95a90afe051
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDdbe8d4f6-c338-4076-9ae9-2e86c07672261
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD95827e99-91d8-3ba6-e053-2a95a90afe051
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDb129e54a-a6d8-42c0-baac-e8db2487369b1
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYdbe8d4f6-c338-4076-9ae9-2e86c07672261
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY95827e99-91d8-3ba6-e053-2a95a90afe051
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYb129e54a-a6d8-42c0-baac-e8db2487369b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2656-160505265601100 TABLET in 1 BOTTLE (60505-2656-1) 100 tablet2009-09-210000-00-00NoNoCurrent
60505-2656-560505265605500 TABLET in 1 BOTTLE (60505-2656-5) 500 tablet2009-09-210000-00-00NoNoCurrent
60505-2656-7605052656076500 TABLET in 1 BOTTLE (60505-2656-7) 6500 tablet2009-09-210000-00-00NoNoCurrent