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United States · US · US:0069-3070_e15f2173-8700-4392-96a4-8560772b6f8a

Zithromax

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerPfizer Laboratories Div Pfizer Inc
CountryUS (United States)
ATC codeJ01FA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0069307030
    30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30)
  • ndc11
    0069307075
    3 BLISTER PACK in 1 CARTON (0069-3070-75) / 3 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
N050784
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Azithromycin Tablet
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": {
    "db52b91e-79f7-4cc1-9564-f2eee8e31c45": {
      "match": "brand_token",
      "title": "ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC]",
      "spl_version": "48",
      "published_date": "2026-01-08"
    }
  },
  "productid": "0069-3070_e15f2173-8700-4392-96a4-8560772b6f8a",
  "productndc": "0069-3070",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "050784",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "001",
        "approval_date": "May 24, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZITHROMYCIN DIHYDRATE",
  "shortage_reason": "Azithromycin Tablet",
  "shortage_status": "current",
  "proprietary_name": "Zithromax",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA050784",
  "marketing_category": "NDA",
  "nonproprietary_name": "azithromycin dihydrate",
  "start_marketing_date": "20020524",
  "active_numerator_strength": "500"
}

Related drugs

Other records sharing ATC code J01FA10.

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