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United States · US · US:71053-591_4b1cda4c-c117-7a42-e063-6294a90a14e2

N/A

In shortageUNIISPLATC A03BA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerRafa Laboratories, Ltd.
CountryUS (United States)
ATC codeA03BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7105359101
    .7 mL in 1 SYRINGE (71053-591-01)

Annotations

UNII (FDA Substance ID)
7C0697DR9I
ATROPINE
RxCUI 1223
DailyMed SPL labels
1 version tracked
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",
  "spl_meta": {
    "4a4fa6e8-0e0a-0e76-e054-00144ff8d46c": {
      "match": "brand_token",
      "title": "N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.]",
      "spl_version": "8",
      "published_date": "2026-02-19"
    }
  },
  "productid": "71053-591_4b1cda4c-c117-7a42-e063-6294a90a14e2",
  "productndc": "71053-591",
  "dosage_form": "INJECTION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ATROPINE",
  "shortage_reason": "Atropine Sulfate Injection",
  "shortage_status": "current",
  "proprietary_name": "N/A",
  "active_ingred_unit": "mg/.7mL",
  "application_number": null,
  "marketing_category": "UNAPPROVED DRUG OTHER",
  "nonproprietary_name": "Atropine Sulfate Injection USP, 1 mg/0.7 mL",
  "start_marketing_date": "20180309",
  "active_numerator_strength": "1"
}

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