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United States · US · US:73687-062_29070ca5-a098-4227-9710-b4a8d1587370

UPNEEQ

Orange BookUNIISPLATC D11AX27

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

Identification

ManufacturerRVL Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeD11AX27
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7368706232
    30 AMPULE in 1 CARTON (73687-062-32) / .3 mL in 1 AMPULE (73687-062-70)
  • ndc11
    7368706268
    5 AMPULE in 1 CARTON (73687-062-68) / .3 mL in 1 AMPULE (73687-062-80)

Annotations

UNII (FDA Substance ID)
K89MJ0S5VY
OXYMETAZOLINE HYDROCHLORIDE
RxCUI 106101
Orange Book
N212520
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "K89MJ0S5VY",
    "rxcui": "106101",
    "inchikey": "BEEDODBODQVSIM-UHFFFAOYSA-N",
    "display_name": "OXYMETAZOLINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "cf6c9a1f-2367-46d2-99c3-c7d67ec6f519": {
      "match": "brand_token",
      "title": "UPNEEQ (OXYMETAZOLINE HYDROCHLORIDE OPHTHALMIC) SOLUTION/ DROPS [RVL PHARMACEUTICALS, INC.]",
      "spl_version": "29",
      "published_date": "2025-11-18"
    }
  },
  "productid": "73687-062_29070ca5-a098-4227-9710-b4a8d1587370",
  "productndc": "73687-062",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "212520",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Jul 8, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OXYMETAZOLINE HYDROCHLORIDE",
  "proprietary_name": "UPNEEQ",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212520",
  "marketing_category": "NDA",
  "nonproprietary_name": "Oxymetazoline hydrochloride ophthalmic",
  "start_marketing_date": "20200821",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code D11AX27.

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