naphazoline hci and pheniramine maleate

Generic: naphazoline hydrochloride , pheniramine maleate

Labeler: altaire pharmaceuticals inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name naphazoline hci and pheniramine maleate
Generic Name naphazoline hydrochloride , pheniramine maleate
Labeler altaire pharmaceuticals inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

naphazoline hydrochloride .27 mg/mL, pheniramine maleate 3.15 mg/mL

Manufacturer
Altaire Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59390-177
Product ID 59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078208
Listing Expiration 2026-12-31
Marketing Start 2010-10-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59390177
Hyphenated Format 59390-177

Supplemental Identifiers

RxCUI
1043704
UNII
MZ1131787D NYW905655B

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 naphazoline hci and pheniramine maleate (source: ndc)
Generic Name naphazoline hydrochloride , pheniramine maleate (source: ndc)
Application Number ANDA078208 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .27 mg/mL
  • 3.15 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE, DROPPER (59390-177-13)
source: ndc

Packages (1)

59390-177-13 15 mL in 1 BOTTLE, DROPPER (59390-177-13)

Ingredients (2)

naphazoline hydrochloride (.27 mg/mL) pheniramine maleate (3.15 mg/mL)

Linked Drug Pages (1)

Naphazoline HCI And Pheniramine Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "b78fd969-ee4c-0ea0-e053-2a95a90a480d", "openfda": {"unii": ["MZ1131787D", "NYW905655B"], "rxcui": ["1043704"], "spl_set_id": ["5649c6e2-966f-44d9-b57e-5bb988eb373d"], "manufacturer_name": ["Altaire Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE, DROPPER (59390-177-13)", "package_ndc": "59390-177-13", "marketing_start_date": "20101006"}], "brand_name": "Naphazoline HCI And Pheniramine Maleate", "product_id": "59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d", "dosage_form": "SOLUTION/ DROPS", "product_ndc": "59390-177", "generic_name": "NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE", "labeler_name": "Altaire Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Naphazoline HCI And Pheniramine Maleate", "active_ingredients": [{"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": ".27 mg/mL"}, {"name": "PHENIRAMINE MALEATE", "strength": "3.15 mg/mL"}], "application_number": "ANDA078208", "marketing_category": "ANDA", "marketing_start_date": "20101006", "listing_expiration_date": "20261231"}