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United States · US · US:68382-110_b9165827-6509-4d3c-813a-547929b720da

Bromocriptine mesylate

Orange BookUNIISPLATC G02CB01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeG02CB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6838211001
    100 CAPSULE in 1 BOTTLE (68382-110-01)
  • ndc11
    6838211006
    30 CAPSULE in 1 BOTTLE (68382-110-06)

Annotations

UNII (FDA Substance ID)
FFP983J3OD
BROMOCRIPTINE MESYLATE
RxCUI 142426
Orange Book
A078899
AB
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": "68382-110_b9165827-6509-4d3c-813a-547929b720da",
  "productndc": "68382-110",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078899",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 30, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BROMOCRIPTINE MESYLATE",
  "proprietary_name": "Bromocriptine mesylate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078899",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bromocriptine mesylate",
  "start_marketing_date": "20090123",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code G02CB01.

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