azithromycin dihydrate

In shortageOrange BookUNIISPLATC J01FA10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSlate Run Pharmaceuticals, LLC

CountryUS (United States)

ATC codeJ01FA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7043622236
1 BOTTLE in 1 CARTON (70436-222-36) / 30 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5FD1131I7S

AZITHROMYCIN DIHYDRATE

RxCUI 253155

Orange Book

A217036

ABAB

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": "70436-222_32f66ed6-7a90-559b-e063-6394a90aaf93",
  "productndc": "70436-222",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217036",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jul 27, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Jul 27, 2023"
      }
    ],
    "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 dihydrate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA217036",
  "marketing_category": "ANDA",
  "nonproprietary_name": "azithromycin dihydrate",
  "start_marketing_date": "20240101",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J01FA10.

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