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United States · US · US:70771-1076_465671c3-1e82-41d6-8ce4-b524d0032b15

CYPROHEPTADINE HYDROCHLORIDE

Orange BookUNIISPLATC R06AX02

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

Identification

ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC codeR06AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7077110760
    1000 TABLET in 1 BOTTLE (70771-1076-0)
  • ndc11
    7077110761
    100 TABLET in 1 BOTTLE (70771-1076-1)

Annotations

UNII (FDA Substance ID)
NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDE
RxCUI 104592
Orange Book
A208938
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": "70771-1076_465671c3-1e82-41d6-8ce4-b524d0032b15",
  "productndc": "70771-1076",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "208938",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "May 19, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "proprietary_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208938",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CYPROHEPTADINE HYDROCHLORIDE",
  "start_marketing_date": "20170720",
  "active_numerator_strength": "4"
}

Related drugs

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