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United States · US · US:24208-416_4e5bdc52-d1c0-760f-e063-6294a90a0264

Retisert

Orange BookUNIISPLATC S01BA15

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01BA15
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

Annotations

UNII (FDA Substance ID)
0CD5FD6S2M
FLUOCINOLONE ACETONIDE
RxCUI 4461
Orange Book
N021737
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0CD5FD6S2M",
    "rxcui": "4461",
    "inchikey": "FEBLZLNTKCEFIT-VSXGLTOVSA-N",
    "display_name": "FLUOCINOLONE ACETONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVITREAL",
  "spl_meta": {
    "1ab0f849-2a0d-47ce-ad05-768094da8cc9": {
      "match": "brand_token",
      "title": "RETISERT (FLUOCINOLONE ACETONIDE) IMPLANT [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "16",
      "published_date": "2026-04-02"
    }
  },
  "productid": "24208-416_4e5bdc52-d1c0-760f-e063-6294a90a0264",
  "productndc": "24208-416",
  "dosage_form": "IMPLANT",
  "orange_book": {
    "appl_no": "021737",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.59MG",
        "product_no": "001",
        "approval_date": "Apr 8, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUOCINOLONE ACETONIDE",
  "proprietary_name": "Retisert",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021737",
  "marketing_category": "NDA",
  "nonproprietary_name": "Fluocinolone Acetonide",
  "start_marketing_date": "20050408",
  "active_numerator_strength": ".59"
}

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