FDA.reportPublic FDA data

Amiloride Hydrochloride

Product NDC
49884-117
11-digit product format
498840117
Labeler code
49884
Product ID
49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiloride Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA070346
Marketing category
ANDA
Marketing start
1986-01-22
Substance
AMILORIDE HYDROCHLORIDE ANHYDROUS
Active strength
5 mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiloride Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMILORIDE HYDROCHLORIDE ANHYDROUS5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7M458Q65S3
Rxcui977880

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7954898a-d540-405e-aa1d-3553358552e5Product name120150812

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-117-01Amiloride Hydrochloride100 in 1 BOTTLETABLET10011
49884-117-10Amiloride Hydrochloride1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-117-01EA - Each49884-117144252bb-d636-4336-9640-7e82ae8c6edd12012-07-24
49884-117-10EA - Each49884-1173e010261-3856-4a92-87de-c6f93ddda7d712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMILORIDE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT7M458Q65S3AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
AMILORIDEACTIVE MOIETY7DZO8EB0Z3AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMILORIDE HYDROCHLORIDE TABLET [PAR PHARMACEUTICAL INC.]5
AMILORIDE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENT7M458Q65S3AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
AMILORIDEACTIVE MOIETY7DZO8EB0Z3AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPAMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMILORIDE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-117AMILORIDE HYDROCHLORIDE TABLET [ENDO USA, INC.]11Current NDC, Legacy NDC, 2 package rows20250109_e0cc2d44-436a-47e8-a890-589882fff4c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
977880aMILoride HCl 5 MG Oral TabletPSN18d551a9-ffc7-4b14-adbd-92d84aa8e966103
977880amiloride hydrochloride 5 MG Oral TabletSCD18d551a9-ffc7-4b14-adbd-92d84aa8e966103
977880aMILoride HCl 5 MG Oral TabletPSNe0cc2d44-436a-47e8-a890-589882fff4c411
977880amiloride hydrochloride 5 MG Oral TabletSCDe0cc2d44-436a-47e8-a890-589882fff4c411
977880aMILoride HCl 5 MG Oral TabletPSN875f3f5a-ed45-4646-8537-21f054302d6f4
977880amiloride hydrochloride 5 MG Oral TabletSCD875f3f5a-ed45-4646-8537-21f054302d6f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-117-0149884011701100 TABLET in 1 BOTTLE (49884-117-01) 100 tablet1986-05-120000-00-00NoNoCurrent
49884-117-10498840117101000 TABLET in 1 BOTTLE (49884-117-10) 1000 tablet1986-05-120000-00-00NoNoCurrent