Atropine Sulfate

In shortageOrange BookUNIISPLATC A03BA01

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

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC codeA03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006964125
25 VIAL in 1 CARTON (70069-641-25) / 1 mL in 1 VIAL (70069-641-01)

Annotations

UNII (FDA Substance ID)

03J5ZE7KA5

ATROPINE SULFATE

RxCUI 153971

Orange Book

A215969

APAP

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": "70069-641_7a8a5552-fe21-4d36-8396-b7c99f41b4c4",
  "productndc": "70069-641",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "215969",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.4MG/ML (0.4MG/ML)",
        "product_no": "001",
        "approval_date": "Jul 3, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Jul 3, 2024"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA215969",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Atropine Sulfate",
  "start_marketing_date": "20240704",
  "active_numerator_strength": "1"
}

Related drugs

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