Triamterene hydrochlorothiazide

Product NDC
21695-496
11-digit product format
216950496
Labeler code
21695
Product ID
21695-496_1061baaf-53f8-4a92-b90f-bcecdf1d183e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA072011
Marketing category
ANDA
Marketing start
1988-06-17
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
38 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
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8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
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f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-496-30Triamterene hydrochlorothiazide30 in 1 BOTTLETABLET301
21695-496-90Triamterene hydrochlorothiazide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-496-30EA - Each21695-496e96f3071-8af8-45ce-aa57-da026a2f32fd12012-07-24
21695-496-90EA - Each21695-4963f9334e0-4687-4c03-81c7-e2f62710664e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TriamtereneACTIVE INGREDIENTWS821Z52LQTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
TriamtereneACTIVE MOIETYWS821Z52LQTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOTRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-496TRIAMTERENE HYDROCHLOROTHIAZIDE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101210_1061baaf-53f8-4a92-b90f-bcecdf1d183e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN1061baaf-53f8-4a92-b90f-bcecdf1d183e1
310818triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral TabletPSN1061baaf-53f8-4a92-b90f-bcecdf1d183e1
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCD1061baaf-53f8-4a92-b90f-bcecdf1d183e1
310818hydrochlorothiazide 50 MG / triamterene 75 MG Oral TabletSCD1061baaf-53f8-4a92-b90f-bcecdf1d183e1
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSY1061baaf-53f8-4a92-b90f-bcecdf1d183e1
310818HCTZ 50 MG / triamterene 75 MG Oral TabletSY1061baaf-53f8-4a92-b90f-bcecdf1d183e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-496-302169504963030 in 1 BOTTLEHistorical
21695-496-902169504969090 in 1 BOTTLEHistorical