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United States · US · US:0487-9901_30dbae21-c906-0624-e063-6394a90a299c

Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerNephron Pharmaceuticals Corporation
CountryUS (United States)
ATC codeR03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0487990102
    30 BAG in 1 BOX (0487-9901-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0487990130
    30 POUCH in 1 CARTON (0487-9901-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A075664
AN
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Albuterol Sulfate Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "021SEF3731",
    "rxcui": "142153",
    "inchikey": "BNPSSFBOAGDEEL-UHFFFAOYSA-N",
    "display_name": "ALBUTEROL SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "b0a5da99-6553-4088-ae27-7fa194438340": {
      "match": "brand_token",
      "title": "ALBUTEROL SULFATE INHALANT [AMERICAN HEALTH PACKAGING]",
      "spl_version": "3",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0487-9901_30dbae21-c906-0624-e063-6394a90a299c",
  "productndc": "0487-9901",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075664",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Jun 26, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALBUTEROL SULFATE",
  "shortage_reason": "Albuterol Sulfate Solution",
  "shortage_status": "current",
  "proprietary_name": "Albuterol Sulfate",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "ANDA075664",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20010626",
  "active_numerator_strength": "2.5"
}

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