Back to search
🇺🇸

United States · US · US:70954-978_45243870-6592-4cdf-a2a1-2e8ea48a47d8

Bromocriptine Mesylate

Orange BookUNIISPLATC G02CB01

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

Identification

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

Packs · 2

  • ndc11
    7095497810
    30 TABLET in 1 BOTTLE (70954-978-10)
  • ndc11
    7095497820
    100 TABLET in 1 BOTTLE (70954-978-20)

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": "70954-978_45243870-6592-4cdf-a2a1-2e8ea48a47d8",
  "productndc": "70954-978",
  "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        "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "20250615",
  "active_numerator_strength": "2.5"
}

Related drugs

Other records sharing ATC code G02CB01.

Access this data programmatically

Query Bromocriptine Mesylate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.