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United States · US · US:0378-7096_caaa8c54-ee5c-47a9-8455-1f49fab45143

Bromocriptine Mesylate

Orange BookUNIISPLATC G02CB01

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

Identification

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

Packs · 2

  • ndc11
    0378709601
    100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-01)
  • ndc11
    0378709693
    30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93)

Annotations

UNII (FDA Substance ID)
FFP983J3OD
BROMOCRIPTINE MESYLATE
RxCUI 142426
Orange Book
A077226
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": "0378-7096_caaa8c54-ee5c-47a9-8455-1f49fab45143",
  "productndc": "0378-7096",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077226",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 4, 2005"
      }
    ],
    "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": "ANDA077226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bromocriptine mesylate",
  "start_marketing_date": "20130617",
  "active_numerator_strength": "5"
}

Related drugs

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