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United States · US · US:68382-860_c4849b63-a84f-4cf0-b937-7ca4b33f2d25
Benztropine Mesylate
In shortageOrange BookUNIISPLATC N04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168382860105 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02)
Annotations
UNII (FDA Substance ID)
WMJ8TL7510
BENZTROPINE MESYLATE
RxCUI 18927
Orange Book
A091525
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Benztropine Mesylate Injection
Raw payload (JSON)
{
"unii": {
"unii": "WMJ8TL7510",
"rxcui": "18927",
"inchikey": "CPFJLLXFNPCTDW-BWSPSPBFSA-N",
"display_name": "BENZTROPINE MESYLATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"52bd605a-6a28-c2ec-e063-6294a90a8371": {
"match": "brand_token",
"title": "BENZTROPINE MESYLATE TABLET [COUPLER LLC]",
"spl_version": "1",
"published_date": "2026-05-28"
}
},
"productid": "68382-860_c4849b63-a84f-4cf0-b937-7ca4b33f2d25",
"productndc": "68382-860",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "091525",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Feb 5, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BENZTROPINE MESYLATE",
"shortage_reason": "Benztropine Mesylate Injection",
"shortage_status": "current",
"proprietary_name": "Benztropine Mesylate",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA091525",
"marketing_category": "ANDA",
"nonproprietary_name": "Benztropine Mesylate",
"start_marketing_date": "20201230",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code N04AC01.
- FIAkitanOrion Corporation Orion Pharma
- GBBenzatropine 1mg tabletsSpecial Order
- GBBenzatropine 1mg/5ml oral solutionSpecial Order
- GBBenzatropine 2mg tabletsSpecial Order
- GBBenzatropine 2mg/2ml solution for injection vialsImported
- 🇺🇸Benztropine MesylateCoupler LLC
- 🇺🇸Benztropine MesylateCipla USA Inc.
- 🇺🇸Benztropine MesylateChartwell RX, LLC.
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