Atropine Sulfate

In shortageOrange BookUNIISPLATC A03BA01

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

Identification

ManufacturerBausch & Lomb Incorporated

CountryUS (United States)

ATC codeA03BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2420896501
10 VIAL in 1 CARTON (24208-965-01) / .4 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

03J5ZE7KA5

ATROPINE SULFATE

RxCUI 153971

Orange Book

N213581

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": "OPHTHALMIC",
  "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": "24208-965_32c411c4-f4b0-fc14-e063-6394a90a2955",
  "productndc": "24208-965",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "213581",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Mar 15, 2022"
      }
    ],
    "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": "NDA213581",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atropine Sulfate",
  "start_marketing_date": "20220713",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A03BA01.

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