albuterol sulfate

Generic: albuterol sulfate

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

albuterol sulfate 2 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-189
Product ID 68999-189_462ca25f-d461-c069-e063-6394a90a528a
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 68999189
Hyphenated Format 68999-189

Supplemental Identifiers

RxCUI
755497
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 (68999-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20)
  • 2 TRAY in 1 BOX (68999-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-189-05)
source: ndc

Packages (2)

68999-189-23 2 TRAY in 1 BOX (68999-189-23) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20) 68999-189-24 2 TRAY in 1 BOX (68999-189-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-189-05)

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": "462ca25f-d461-c069-e063-6394a90a528a", "openfda": {"unii": ["021SEF3731"], "rxcui": ["755497"], "spl_set_id": ["dd47559a-84f6-42a5-a00e-48754505418e"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-189-23)  / 10 CUP in 1 TRAY / 20 mL in 1 CUP (68999-189-20)", "package_ndc": "68999-189-23", "marketing_start_date": "20251215"}, {"sample": false, "description": "2 TRAY in 1 BOX (68999-189-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-189-05)", "package_ndc": "68999-189-24", "marketing_start_date": "20251215"}], "brand_name": "ALBUTEROL SULFATE", "product_id": "68999-189_462ca25f-d461-c069-e063-6394a90a528a", "dosage_form": "SYRUP", "pharm_class": ["Adrenergic beta2-Agonists [MoA]", "beta2-Adrenergic Agonist [EPC]"], "product_ndc": "68999-189", "generic_name": "Albuterol Sulfate", "labeler_name": "Chartwell Governmental & Specialty 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"}