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United States · US · US:78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b

CELESTONE SOLUSPAN

Orange BookUNIISPLATC A07EA

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeA07EA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820611801
    1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
TI05AO53L7
BETAMETHASONE ACETATE
RxCUI 1516
Orange Book
N014602
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TI05AO53L7",
    "rxcui": "1516",
    "inchikey": "AKUJBENLRBOFTD-QZIXMDIESA-N",
    "display_name": "BETAMETHASONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE",
  "spl_meta": {
    "95a19c2f-c329-4ce1-a0a7-174814aac3ad": {
      "match": "brand_token",
      "title": "CELESTONE SOLUSPAN (BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE) INJECTION, SUSPENSION [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b",
  "productndc": "78206-118",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "014602",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "3MG/ML;EQ 3MG BASE/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE",
  "proprietary_name": "CELESTONE SOLUSPAN",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA014602",
  "marketing_category": "NDA",
  "nonproprietary_name": "Betamethasone Acetate and Betamethasone Sodium Phosphate",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "3; 3"
}

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