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United States · US · US:71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6

Azithromycin

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01FA10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7120515803
    3 TABLET, FILM COATED in 1 BOTTLE (71205-158-03)
  • ndc11
    7120515806
    6 TABLET, FILM COATED in 1 BOTTLE (71205-158-06)
  • ndc11
    7120515830
    30 TABLET, FILM COATED in 1 BOTTLE (71205-158-30)
  • ndc11
    7120515866
    1 BLISTER PACK in 1 CARTON (71205-158-66) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A207370
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": "71205-158_d47fa421-e017-48f1-95a9-c0922cca63d6",
  "productndc": "71205-158",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207370",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Jul 5, 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": "ANDA207370",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azithromycin",
  "start_marketing_date": "20180705",
  "active_numerator_strength": "250"
}

Related drugs

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