Benztropine Mesylate

In shortageOrange BookUNIISPLATC N04AC01

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeN04AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0603243321
100 TABLET in 1 BOTTLE, PLASTIC (0603-2433-21)
ndc11
0603243332
1000 TABLET in 1 BOTTLE, PLASTIC (0603-2433-32)

Annotations

UNII (FDA Substance ID)

WMJ8TL7510

BENZTROPINE MESYLATE

RxCUI 18927

Orange Book

A040715

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": "0603-2433_f572eba2-cce7-4e65-9df4-9c0585530c0b",
  "productndc": "0603-2433",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040715",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Aug 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Aug 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Aug 27, 2007"
      }
    ],
    "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": "ANDA040715",
  "marketing_category": "ANDA",
  "nonproprietary_name": "benztropine mesylate",
  "start_marketing_date": "20220317",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code N04AC01.

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