ATROPEN Auto-Injector

In shortageOrange BookUNIIATC A03BA01

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

Identification

ManufacturerMeridian Medical Technologies LLC

CountryUS (United States)

ATC codeA03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1170410401
.7 mL in 1 SYRINGE, PLASTIC (11704-104-01)

Annotations

UNII (FDA Substance ID)

7C0697DR9I

ATROPINE

RxCUI 1223

Orange Book

N017106

FDA shortage

Currently in shortage

Atropine Sulfate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "7C0697DR9I",
    "rxcui": "1223",
    "inchikey": "RKUNBYITZUJHSG-JJXSEGSLSA-N;RKUNBYITZUJHSG-FXUDXRNXSA-N",
    "display_name": "ATROPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR",
  "productid": "11704-104_f1736bb6-219c-48dd-969d-f26f6fbad350",
  "productndc": "11704-104",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "017106",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 2MG SULFATE/0.7ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1MG SULFATE/0.7ML",
        "product_no": "002",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.5MG SULFATE/0.7ML",
        "product_no": "003",
        "approval_date": "Jun 19, 2003"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.25MG SULFATE/0.3ML",
        "product_no": "004",
        "approval_date": "Sep 17, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "ATROPEN Auto-Injector",
  "active_ingred_unit": "mg/.7mL",
  "application_number": "NDA017106",
  "marketing_category": "NDA",
  "nonproprietary_name": "atropine",
  "start_marketing_date": "20030619",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code A03BA01.

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