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United States · US · US:59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d

Naphazoline HCI And Pheniramine Maleate

Orange BookUNIIATC R01AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAltaire Pharmaceuticals Inc.
CountryUS (United States)
ATC codeR01AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5939017713
    15 mL in 1 BOTTLE, DROPPER (59390-177-13)

Annotations

UNII (FDA Substance ID)
MZ1131787D
NAPHAZOLINE HYDROCHLORIDE
RxCUI 82054
Orange Book
A078208
Raw payload (JSON)
{
  "unii": {
    "unii": "MZ1131787D",
    "rxcui": "82054",
    "inchikey": "DJDFFEBSKJCGHC-UHFFFAOYSA-N",
    "display_name": "NAPHAZOLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "productid": "59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d",
  "productndc": "59390-177",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "078208",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.02675%;0.315%",
        "product_no": "001",
        "approval_date": "Sep 27, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE",
  "proprietary_name": "Naphazoline HCI And Pheniramine Maleate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA078208",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE",
  "start_marketing_date": "20101006",
  "active_numerator_strength": ".27; 3.15"
}

Related drugs

Other records sharing ATC code R01AA.

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