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United States · US · US:62332-251_ec17228a-6191-4f77-8ae2-00da7c85fca3

Azithromycin

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeJ01FA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6233225106
    18 BLISTER PACK in 1 CARTON (62332-251-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6233225118
    18 BLISTER PACK in 1 CARTON (62332-251-18) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6233225130
    30 TABLET, FILM COATED in 1 BOTTLE (62332-251-30)
  • ndc11
    6233225171
    500 TABLET, FILM COATED in 1 BOTTLE (62332-251-71)
  • ndc11
    6233225191
    1000 TABLET, FILM COATED in 1 BOTTLE (62332-251-91)

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A211791
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": "62332-251_ec17228a-6191-4f77-8ae2-00da7c85fca3",
  "productndc": "62332-251",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211791",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jan 28, 2020"
      }
    ],
    "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": "ANDA211791",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azithromycin",
  "start_marketing_date": "20200129",
  "active_numerator_strength": "250"
}

Related drugs

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