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United States · US · US:64980-641_325090e0-82fc-be8c-e063-6294a90a45a1

Albuterol Sulfate

In shortageOrange BookUNIISPLATC R03AC02

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeR03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6498064102
    1 POUCH in 1 CARTON (64980-641-02) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6498064103
    1 POUCH in 1 CARTON (64980-641-03) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    6498064106
    2 POUCH in 1 CARTON (64980-641-06) / 30 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
021SEF3731
ALBUTEROL SULFATE
RxCUI 142153
Orange Book
A074880
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": "64980-641_325090e0-82fc-be8c-e063-6294a90a45a1",
  "productndc": "64980-641",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "074880",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "EQ 0.083% BASE",
        "product_no": "001",
        "approval_date": "Sep 17, 1997"
      }
    ],
    "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/3mL",
  "application_number": "ANDA074880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Albuterol Sulfate",
  "start_marketing_date": "20250314",
  "active_numerator_strength": "2.5"
}

Related drugs

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