N/A

In shortageOrange BookUNIISPLATC A03BA01

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

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
7105359201
480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

7C0697DR9I

ATROPINE

RxCUI 1223

Orange Book

N212319

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": "71053-592_4b1cda4c-c117-7a42-e063-6294a90a14e2",
  "productndc": "71053-592",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212319",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML)",
        "product_no": "001",
        "approval_date": "Jul 9, 2018"
      }
    ],
    "appl_type": "N"
  },
  "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": "NDA212319",
  "marketing_category": "NDA",
  "nonproprietary_name": "Atropine Injection, 2 mg",
  "start_marketing_date": "20180709",
  "active_numerator_strength": "2"
}

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