Amiloride Hydrochloride

Product NDC
63629-2114
11-digit product format
636292114
Labeler code
63629
Product ID
63629-2114_84adc61b-3ed3-452d-a1b8-d062869b263d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiloride Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-2114-1Amiloride Hydrochloride1000 in 1 BOTTLETABLET1000103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2114-1EA - Each63629-21143d35f8ab-1fc1-4476-9caf-8833c9dde5ed12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2114AMILORIDE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20231129_18d551a9-ffc7-4b14-adbd-92d84aa8e966.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2114-1636292114011000 TABLET in 1 BOTTLE (63629-2114-1) 1000 tablet1986-05-120000-00-00NoNoCurrent