BENZTROPINE MESYLATE

In shortageOrange BookUNIISPLATC N04AC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeN04AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7161050253
60 TABLET in 1 BOTTLE (71610-502-53)

Annotations

UNII (FDA Substance ID)

WMJ8TL7510

BENZTROPINE MESYLATE

RxCUI 18927

Orange Book

A090168

AAAAAA

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": "ORAL",
  "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": "71610-502_83880a96-336b-4e03-ac29-a41e62d78f3c",
  "productndc": "71610-502",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "090168",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Nov 28, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Nov 28, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Nov 28, 2012"
      }
    ],
    "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/1",
  "application_number": "ANDA090168",
  "marketing_category": "ANDA",
  "nonproprietary_name": "BENZTROPINE MESYLATE",
  "start_marketing_date": "20121128",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code N04AC01.

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