albuterol

Generic: albuterol sulfate

Labeler: nivagen pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol
Generic Name albuterol sulfate
Labeler nivagen pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

albuterol sulfate 4 mg/1

Manufacturer
Nivagen Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 75834-274
Product ID 75834-274_5b89a3bb-e3bb-421d-89f7-f180e01a1b4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210948
Listing Expiration 2026-12-31
Marketing Start 2021-01-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834274
Hyphenated Format 75834-274

Supplemental Identifiers

RxCUI
197316 197318
UPC
0375834274010 0375834273013
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 (source: ndc)
Generic Name albuterol sulfate (source: ndc)
Application Number ANDA210948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01)
source: ndc

Packages (1)

75834-274-01 100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01)

Ingredients (1)

albuterol sulfate (4 mg/1)

Linked Drug Pages (1)

Albuterol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5b89a3bb-e3bb-421d-89f7-f180e01a1b4d", "openfda": {"upc": ["0375834274010", "0375834273013"], "unii": ["021SEF3731"], "rxcui": ["197316", "197318"], "spl_set_id": ["b735e92d-eb1a-6fc1-e053-2995a90afce2"], "manufacturer_name": ["Nivagen Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (75834-274-01)", "package_ndc": "75834-274-01", "marketing_start_date": "20210121"}], "brand_name": "Albuterol", "product_id": "75834-274_5b89a3bb-e3bb-421d-89f7-f180e01a1b4d", "dosage_form": "TABLET", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "75834-274", "generic_name": "albuterol sulfate", "labeler_name": "Nivagen Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Albuterol", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "4 mg/1"}], "application_number": "ANDA210948", "marketing_category": "ANDA", "marketing_start_date": "20210121", "listing_expiration_date": "20261231"}