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United States · US · US:0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5

azithromycin

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

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

Packs · 2

  • ndc11
    0527237020
    6 TABLET, FILM COATED in 1 BLISTER PACK (0527-2370-20)
  • ndc11
    0527237032
    30 TABLET, FILM COATED in 1 BOTTLE (0527-2370-32)

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A209045
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": {
    "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": "0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5",
  "productndc": "0527-2370",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209045",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Dec 7, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AZITHROMYCIN DIHYDRATE",
  "shortage_reason": "Azithromycin Tablet",
  "shortage_status": "current",
  "proprietary_name": "azithromycin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209045",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AZITHROMYCIN",
  "start_marketing_date": "20190704",
  "active_numerator_strength": "250"
}

Related drugs

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