Atropine Sulfate

In shortageOrange BookUNIISPLATC A03BA01

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeA03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409963005
10 CARTON in 1 PACKAGE (0409-9630-05) / 1 SYRINGE, PLASTIC in 1 CARTON / 5 mL in 1 SYRINGE, PLASTIC (0409-9630-15)

Annotations

UNII (FDA Substance ID)

03J5ZE7KA5

ATROPINE SULFATE

RxCUI 153971

Orange Book

N021146

APAPAP

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": "INTRAVENOUS",
  "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": "0409-9630_3f33c683-46fb-40db-af0d-9211bc29d2a7",
  "productndc": "0409-9630",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021146",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jul 9, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.25MG/5ML (0.05MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 9, 2001"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/10ML (0.1MG/ML)",
        "product_no": "003",
        "approval_date": "Jul 9, 2001"
      }
    ],
    "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": "NDA021146",
  "marketing_category": "NDA",
  "nonproprietary_name": "ATROPINE SULFATE",
  "start_marketing_date": "20041231",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code A03BA01.

Access this data programmatically

Query Atropine Sulfate 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