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United States · US · US:70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111

Azithromycin

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerAthenex Pharmaceutical Division, LLC.
CountryUS (United States)
ATC codeJ01FA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7086010010
    10 VIAL, SINGLE-DOSE in 1 CARTON (70860-100-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70860-100-41)

Annotations

UNII (FDA Substance ID)
JTE4MNN1MD
AZITHROMYCIN MONOHYDRATE
RxCUI 1298839
Orange Book
A065501
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "JTE4MNN1MD",
    "rxcui": "1298839",
    "inchikey": "HQUPLSLYZHKKQT-WVVFQGGUSA-N",
    "display_name": "AZITHROMYCIN MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b5d79719-b1dc-469f-a19c-f8ba615138f0": {
      "match": "brand_token",
      "title": "AZITHROMYCIN TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-05-20"
    }
  },
  "productid": "70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111",
  "productndc": "70860-100",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065501",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 9, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZITHROMYCIN MONOHYDRATE",
  "shortage_reason": "Azithromycin Injection",
  "shortage_status": "current",
  "proprietary_name": "Azithromycin",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065501",
  "marketing_category": "ANDA",
  "nonproprietary_name": "azithromycin monohydrate",
  "start_marketing_date": "20170101",
  "active_numerator_strength": "500"
}

Related drugs

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