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United States · US · US:0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0a

Mirvaso

Orange BookUNIISPLATC S01GA07

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

Identification

ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeS01GA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    0299598000
    1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBE
  • ndc11
    0299598002
    2 g in 1 TUBE (0299-5980-02)
  • ndc11
    0299598030
    30 g in 1 TUBE (0299-5980-30)
  • ndc11
    0299598035
    1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMP
  • ndc11
    0299598045
    45 g in 1 TUBE (0299-5980-45)

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
N204708
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4S9CL2DY2H",
    "rxcui": "39171",
    "inchikey": "QZHBYNSSDLTCRG-LREBCSMRSA-N",
    "display_name": "BRIMONIDINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "f6a4353f-ae69-4214-901f-e5d42a6fbde7": {
      "match": "brand_token",
      "title": "MIRVASO (BRIMONIDINE TARTRATE) GEL [GALDERMA LABORATORIES, L.P.]",
      "spl_version": "11",
      "published_date": "2024-10-28"
    }
  },
  "productid": "0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0a",
  "productndc": "0299-5980",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "204708",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.33% BASE",
        "product_no": "001",
        "approval_date": "Aug 23, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE",
  "proprietary_name": "Mirvaso",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA204708",
  "marketing_category": "NDA",
  "nonproprietary_name": "brimonidine tartrate",
  "start_marketing_date": "20130823",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code S01GA07.

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