albuterol sulfate

Generic: albuterol sulfate

Labeler: nephron pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler nephron pharmaceuticals corporation
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

albuterol sulfate 2.5 mg/.5mL

Manufacturer
Nephron Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0487-9901
Product ID 0487-9901_30dbae21-c906-0624-e063-6394a90a299c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075664
Listing Expiration 2026-12-31
Marketing Start 2001-06-26

Pharmacologic Class

Classes
adrenergic beta2-agonists [moa] beta2-adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04879901
Hyphenated Format 0487-9901

Supplemental Identifiers

RxCUI
245314
UNII
021SEF3731

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name albuterol sulfate (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA075664 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/.5mL
source: ndc
Packaging
  • 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
  • 30 POUCH in 1 CARTON (0487-9901-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0487-9901-02 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 0487-9901-30 30 POUCH in 1 CARTON (0487-9901-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

albuterol sulfate (2.5 mg/.5mL)

Linked Drug Pages (1)

Albuterol Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "30dbae21-c906-0624-e063-6394a90a299c", "openfda": {"unii": ["021SEF3731"], "rxcui": ["245314"], "spl_set_id": ["ecc00500-58b8-491f-80df-dc6c89a08cae"], "manufacturer_name": ["Nephron Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "0487-9901-02", "marketing_start_date": "20010626"}, {"sample": false, "description": "30 POUCH in 1 CARTON (0487-9901-30)  / 1 VIAL, SINGLE-DOSE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0487-9901-30", "marketing_start_date": "20010626"}], "brand_name": "Albuterol Sulfate", "product_id": "0487-9901_30dbae21-c906-0624-e063-6394a90a299c", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "0487-9901", "generic_name": "Albuterol Sulfate", "labeler_name": "Nephron Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol Sulfate", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2.5 mg/.5mL"}], "application_number": "ANDA075664", "marketing_category": "ANDA", "marketing_start_date": "20010626", "listing_expiration_date": "20261231"}