BENZTROPINE MESYLATE

In shortageOrange BookUNIISPLATC N04AC01

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

Identification

ManufacturerLeading Pharma, LLC

CountryUS (United States)

ATC codeN04AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6931513801
100 TABLET in 1 BOTTLE (69315-138-01)
ndc11
6931513810
1000 TABLET in 1 BOTTLE (69315-138-10)

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": "69315-138_f61e0118-7898-42cf-9e27-e5f2dabe6ea4",
  "productndc": "69315-138",
  "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": "2"
}

Related drugs

Other records sharing ATC code N04AC01.

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