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United States · US · US:60687-931_51911920-109b-a9be-e063-6394a90a733f

Bromocriptine Mesylate

Orange BookUNIISPLATC G02CB01

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

Identification

ManufacturerAmerican Health Packaging
CountryUS (United States)
ATC codeG02CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6068793121
    30 BLISTER PACK in 1 CARTON (60687-931-21) / 1 TABLET in 1 BLISTER PACK (60687-931-11)

Annotations

UNII (FDA Substance ID)
FFP983J3OD
BROMOCRIPTINE MESYLATE
RxCUI 142426
Orange Book
N017962
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "FFP983J3OD",
    "rxcui": "142426",
    "inchikey": "NOJMTMIRQRDZMT-GSPXQYRGSA-N",
    "display_name": "BROMOCRIPTINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ddd292a5-72af-448f-8b88-cc4fd99ec783": {
      "match": "brand_token",
      "title": "BROMOCRIPTINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING]",
      "spl_version": "1",
      "published_date": "2026-05-13"
    }
  },
  "productid": "60687-931_51911920-109b-a9be-e063-6394a90a733f",
  "productndc": "60687-931",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "017962",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Mar 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BROMOCRIPTINE MESYLATE",
  "proprietary_name": "Bromocriptine Mesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bromocriptine Mesylate",
  "start_marketing_date": "20260501",
  "active_numerator_strength": "2.5"
}

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