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United States · US · US:76385-130_d68a0f7b-98e1-4d8c-a236-9d701e4e68d5

Cyproheptadine Hydrochloride

Orange BookUNIISPLATC R06AX02

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

Identification

ManufacturerUNICHEM PHARMACEUTICALS (USA), INC.
CountryUS (United States)
ATC codeR06AX02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7638513001
    100 TABLET in 1 BOTTLE (76385-130-01)
  • ndc11
    7638513010
    1000 TABLET in 1 BOTTLE (76385-130-10)

Annotations

UNII (FDA Substance ID)
NJ82J0F8QC
CYPROHEPTADINE HYDROCHLORIDE
RxCUI 104592
Orange Book
A206676
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": "76385-130_d68a0f7b-98e1-4d8c-a236-9d701e4e68d5",
  "productndc": "76385-130",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206676",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2019"
      }
    ],
    "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": "ANDA206676",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyproheptadine Hydrochloride",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code R06AX02.

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