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United States · US · US:62135-949_06fd9a7b-3b04-6e0c-e063-6394a90aba46

CYPROHEPTADINE

Orange BookUNIISPLATC R06AX02

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

Identification

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

Packs · 2

  • ndc11
    6213594947
    473 mL in 1 BOTTLE (62135-949-47)
  • ndc11
    6213594994
    946 mL in 1 BOTTLE (62135-949-94)

Annotations

UNII (FDA Substance ID)
NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDE
RxCUI 104592
Orange Book
A203191
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "NJ82J0F8QC",
    "rxcui": "104592",
    "inchikey": "ZEAUHIZSRUAMQG-UHFFFAOYSA-N",
    "display_name": "CYPROHEPTADINE HYDROCHLORIDE",
    "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": "62135-949_06fd9a7b-3b04-6e0c-e063-6394a90aba46",
  "productndc": "62135-949",
  "dosage_form": "SYRUP",
  "orange_book": {
    "appl_no": "203191",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 13, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "proprietary_name": "CYPROHEPTADINE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA203191",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "start_marketing_date": "20170713",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code R06AX02.

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