amiloride hydrochloride

Generic: amiloride hydrochloride

Labeler: sigmapharm laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiloride hydrochloride
Generic Name amiloride hydrochloride
Labeler sigmapharm laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiloride hydrochloride anhydrous 5 mg/1

Manufacturer
Sigmapharm Laboratories, LLC

Identifiers & Regulatory

Product NDC 42794-005
Product ID 42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079133
Listing Expiration 2026-12-31
Marketing Start 2021-06-14

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 42794005
Hyphenated Format 42794-005

Supplemental Identifiers

RxCUI
977880
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 ANDA079133 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (42794-005-02)
source: ndc

Packages (1)

42794-005-02 100 TABLET in 1 BOTTLE (42794-005-02)

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": "f1f15fe7-63a8-4708-e053-2a95a90a7dea", "openfda": {"unii": ["7M458Q65S3"], "rxcui": ["977880"], "spl_set_id": ["de12b6f3-3791-4d78-90e6-c487cf951738"], "manufacturer_name": ["Sigmapharm Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (42794-005-02)", "package_ndc": "42794-005-02", "marketing_start_date": "20210614"}], "brand_name": "Amiloride Hydrochloride", "product_id": "42794-005_f1f15fe7-63a8-4708-e053-2a95a90a7dea", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]"], "product_ndc": "42794-005", "generic_name": "Amiloride Hydrochloride", "labeler_name": "Sigmapharm Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiloride Hydrochloride", "active_ingredients": [{"name": "AMILORIDE HYDROCHLORIDE ANHYDROUS", "strength": "5 mg/1"}], "application_number": "ANDA079133", "marketing_category": "ANDA", "marketing_start_date": "20210614", "listing_expiration_date": "20261231"}