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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
- ndc11709549781030 TABLET in 1 BOTTLE (70954-978-10)
- ndc117095497820100 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"strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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.
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- GBBromocriptine 1mg tabletsMeda Pharmaceuticals Ltd
- GBBromocriptine 1mg tabletsFocus Pharmaceuticals Ltd
- GBBromocriptine 1mg tabletsA A H Pharmaceuticals Ltd
- GBBromocriptine 1mg tabletsAlliance Healthcare (Distribution) Ltd
- GBBromocriptine 1mg/5ml oral suspensionSpecial Order
Access this data programmatically
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