Benztropine Mesylate

In shortageOrange BookUNIISPLATC N04AC01

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

Identification

ManufacturerChartwell RX, LLC.

CountryUS (United States)

ATC codeN04AC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6213514201
100 TABLET in 1 BOTTLE, PLASTIC (62135-142-01)
ndc11
6213514210
1000 TABLET in 1 BOTTLE, PLASTIC (62135-142-10)
ndc11
6213514218
180 TABLET in 1 BOTTLE, PLASTIC (62135-142-18)
ndc11
6213514230
30 TABLET in 1 BOTTLE, PLASTIC (62135-142-30)
ndc11
6213514257
540 TABLET in 1 BOTTLE, PLASTIC (62135-142-57)

Annotations

UNII (FDA Substance ID)

WMJ8TL7510

BENZTROPINE MESYLATE

RxCUI 18927

Orange Book

A081265

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": "62135-142_458c005f-8842-3916-e063-6294a90a93b1",
  "productndc": "62135-142",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "081265",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "2MG",
        "product_no": "001",
        "approval_date": "Jan 23, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Jan 23, 1992"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "0.5MG",
        "product_no": "003",
        "approval_date": "Nov 29, 2023"
      }
    ],
    "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": "ANDA081265",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Benztropine mesylate",
  "start_marketing_date": "19920123",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N04AC01.

Access this data programmatically

Query Benztropine Mesylate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs