albuterol sulfate

Generic: albuterol sulfate

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name albuterol sulfate
Generic Name albuterol sulfate
Labeler chartwell rx, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

albuterol sulfate 2 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-189
Product ID 62135-189_316befe4-1351-2acb-e063-6394a90a9a17
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077788
Listing Expiration 2026-12-31
Marketing Start 2007-06-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135189
Hyphenated Format 62135-189

Supplemental Identifiers

RxCUI
755497
UPC
0362135189419 0362135189471
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 ANDA077788 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20)
  • 2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05)
  • 120 mL in 1 CONTAINER (62135-189-41)
  • 473 mL in 1 CONTAINER (62135-189-47)
source: ndc

Packages (4)

62135-189-23 2 TRAY in 1 BOX (62135-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20) 62135-189-24 2 TRAY in 1 BOX (62135-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05) 62135-189-41 120 mL in 1 CONTAINER (62135-189-41) 62135-189-47 473 mL in 1 CONTAINER (62135-189-47)

Ingredients (1)

albuterol sulfate (2 mg/5mL)

Linked Drug Pages (1)

ALBUTEROL SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "316befe4-1351-2acb-e063-6394a90a9a17", "openfda": {"upc": ["0362135189419", "0362135189471"], "unii": ["021SEF3731"], "rxcui": ["755497"], "spl_set_id": ["560df50c-e2c4-459f-9d89-bf7e6588949e"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-189-23)  / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-189-20)", "package_ndc": "62135-189-23", "marketing_start_date": "20250326"}, {"sample": false, "description": "2 TRAY in 1 BOX (62135-189-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-189-05)", "package_ndc": "62135-189-24", "marketing_start_date": "20250326"}, {"sample": false, "description": "120 mL in 1 CONTAINER (62135-189-41)", "package_ndc": "62135-189-41", "marketing_start_date": "20220608"}, {"sample": false, "description": "473 mL in 1 CONTAINER (62135-189-47)", "package_ndc": "62135-189-47", "marketing_start_date": "20220608"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "62135-189_316befe4-1351-2acb-e063-6394a90a9a17", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "62135-189", "generic_name": "Albuterol Sulfate", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALBUTEROL SULFATE", "active_ingredients": [{"name": "ALBUTEROL SULFATE", "strength": "2 mg/5mL"}], "application_number": "ANDA077788", "marketing_category": "ANDA", "marketing_start_date": "20070626", "listing_expiration_date": "20261231"}