amiloride hydrochloride

Generic: amiloride hydrochloride

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiloride hydrochloride
Generic Name amiloride hydrochloride
Labeler endo usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiloride hydrochloride anhydrous 5 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-117
Product ID 49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070346
Listing Expiration 2026-12-31
Marketing Start 1986-01-22

Pharmacologic Class

Classes
decreased renal k+ excretion [pe] increased diuresis [pe] potassium-sparing diuretic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884117
Hyphenated Format 49884-117

Supplemental Identifiers

RxCUI
977880
UPC
0349884117108
UNII
7M458Q65S3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name amiloride hydrochloride (source: ndc)
Generic Name amiloride hydrochloride (source: ndc)
Application Number ANDA070346 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (49884-117-01)
  • 1000 TABLET in 1 BOTTLE (49884-117-10)
source: ndc

Packages (2)

49884-117-01 100 TABLET in 1 BOTTLE (49884-117-01) 49884-117-10 1000 TABLET in 1 BOTTLE (49884-117-10)

Ingredients (1)

amiloride hydrochloride anhydrous (5 mg/1)

Linked Drug Pages (1)

Amiloride Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cee18f3c-6f68-46d0-9e69-72c504c5a798", "openfda": {"upc": ["0349884117108"], "unii": ["7M458Q65S3"], "rxcui": ["977880"], "spl_set_id": ["e0cc2d44-436a-47e8-a890-589882fff4c4"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (49884-117-01)", "package_ndc": "49884-117-01", "marketing_start_date": "19860512"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (49884-117-10)", "package_ndc": "49884-117-10", "marketing_start_date": "19860512"}], "brand_name": "Amiloride Hydrochloride", "product_id": "49884-117_cee18f3c-6f68-46d0-9e69-72c504c5a798", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]"], "product_ndc": "49884-117", "generic_name": "Amiloride Hydrochloride", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiloride Hydrochloride", "active_ingredients": [{"name": "AMILORIDE HYDROCHLORIDE ANHYDROUS", "strength": "5 mg/1"}], "application_number": "ANDA070346", "marketing_category": "ANDA", "marketing_start_date": "19860122", "listing_expiration_date": "20261231"}