Atropine Sulfate

In shortageOrange BookUNIISPLATC A03BA01

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

Identification

ManufacturerProPharma Distribution

CountryUS (United States)

ATC codeA03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8454958020
20 mL in 1 VIAL, MULTI-DOSE (84549-580-20)

Annotations

UNII (FDA Substance ID)

03J5ZE7KA5

ATROPINE SULFATE

RxCUI 153971

Orange Book

N209260

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Atropine Sulfate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "03J5ZE7KA5",
    "rxcui": "153971",
    "inchikey": "JPKKQJKQTPNWTR-WFEZVHBLSA-N;JPKKQJKQTPNWTR-AAWIVWGASA-N",
    "display_name": "ATROPINE SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "ad8916e7-206e-409e-2582-30d072845dd4": {
      "match": "brand_token",
      "title": "ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "31",
      "published_date": "2026-05-20"
    }
  },
  "productid": "84549-580_463c2db1-15a5-da49-e063-6394a90a74bf",
  "productndc": "84549-580",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209260",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "8MG/20ML (0.4MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 26, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE SULFATE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "Atropine Sulfate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209260",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atropine Sulfate",
  "start_marketing_date": "20170123",
  "active_numerator_strength": ".4"
}

Related drugs

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