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United States · US · US:58657-697_41b48ab2-962e-790a-e063-6394a90a6106

cyproheptadine hydrochloride solution

Orange BookUNIISPLATC R06AX02

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

Identification

ManufacturerMethod Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR06AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5865769716
    473 mL in 1 BOTTLE, GLASS (58657-697-16)

Annotations

UNII (FDA Substance ID)
2YHB6175DO
CYPROHEPTADINE
RxCUI 3013
Orange Book
A209108
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2YHB6175DO",
    "rxcui": "3013",
    "inchikey": "JJCFRYNCJDLXIK-UHFFFAOYSA-N",
    "display_name": "CYPROHEPTADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "50b3abc0-d86a-e8f5-e063-6394a90ad25e": {
      "match": "brand_token",
      "title": "CYPROHEPTADINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICAL CORP.]",
      "spl_version": "1",
      "published_date": "2026-05-06"
    }
  },
  "productid": "58657-697_41b48ab2-962e-790a-e063-6394a90a6106",
  "productndc": "58657-697",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209108",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML",
        "product_no": "001",
        "approval_date": "Oct 16, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYPROHEPTADINE",
  "proprietary_name": "cyproheptadine hydrochloride solution",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA209108",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "start_marketing_date": "20240615",
  "active_numerator_strength": "2"
}

Related drugs

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