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United States · US · US:85766-008_49eeafc2-f6d5-2cfd-e063-6394a90a7af6

Azithromycin

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeJ01FA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8576600806
    6 DOSE PACK in 1 CARTON (85766-008-06) / 1 TABLET, FILM COATED in 1 DOSE PACK

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A065211
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "5FD1131I7S",
    "rxcui": "253155",
    "inchikey": "SRMPHJKQVUDLQE-KUJJYQHYSA-N",
    "display_name": "AZITHROMYCIN DIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "85766-008_49eeafc2-f6d5-2cfd-e063-6394a90a7af6",
  "productndc": "85766-008",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065211",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Nov 14, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZITHROMYCIN DIHYDRATE",
  "shortage_reason": "Azithromycin Injection",
  "shortage_status": "current",
  "proprietary_name": "Azithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065211",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azithromycin",
  "start_marketing_date": "20051114",
  "active_numerator_strength": "250"
}

Related drugs

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