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United States · US · US:62332-253_c043ed24-ba88-4465-a0bd-da8531778957

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 · 2

  • ndc11
    6233225310
    100 BLISTER PACK in 1 CARTON (62332-253-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6233225330
    30 TABLET, FILM COATED in 1 BOTTLE (62332-253-30)

Annotations

UNII (FDA Substance ID)
5FD1131I7S
AZITHROMYCIN DIHYDRATE
RxCUI 253155
Orange Book
A211793
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": "62332-253_c043ed24-ba88-4465-a0bd-da8531778957",
  "productndc": "62332-253",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211793",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 600MG BASE",
        "product_no": "001",
        "approval_date": "Jan 27, 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": "ANDA211793",
  "marketing_category": "ANDA",
  "nonproprietary_name": "AZITHROMYCIN",
  "start_marketing_date": "20200128",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code J01FA10.

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