Azithromycin Dihydrate

In shortageOrange BookUNIISPLATC J01FA10

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeJ01FA10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7051841600
6 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0)
ndc11
7051841601
30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1)
ndc11
7051841602
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2)
ndc11
7051841603
1 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7051841604
2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4)
ndc11
7051841605
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)

Annotations

UNII (FDA Substance ID)

5FD1131I7S

AZITHROMYCIN DIHYDRATE

RxCUI 253155

Orange Book

A208250

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": "70518-4160_49d7bf04-15e5-a936-e063-6394a90a12b3",
  "productndc": "70518-4160",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208250",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Apr 17, 2019"
      }
    ],
    "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 Dihydrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208250",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Azithromycin Dihydrate",
  "start_marketing_date": "20240815",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01FA10.

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