NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6327Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6327Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-6327-0500906327001 POUCH in 1 CARTON (50090-6327-0) / 1 AEROSOL in 1 POUCHMarketed from Jan 12, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Budesonide and Formoterol Fumarate Dihydrate
Generic name (nonproprietary)
budesonide and formoterol fumarate dihydrate
Active ingredients
Budesonide — 160 ug/1Formoterol fumarate — 4.5 ug/1
Dosage form
Aerosol
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021929
Marketing start
Listing expires
Other FDA classes
Adrenergic beta2-Agonists (Mechanism)Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 50090-6327_dd1cf8de-0389-4e98-be80-dc164a6dbcffSPL ID dd1cf8de-0389-4e98-be80-dc164a6dbcffSPL set ID 0ce4cd21-ac96-4b39-9e1c-49f86c87fa1aRxCUI 1246304UNII Q3OKS62Q6X, W34SHF8J2K
Pharmacologic class
Corticosteroid; beta2-Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N450090632700 followed by a unit qualifier and the quantity

Package 50090-6327-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 021929

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021929
ProductStrengthForm · routeLabelerProduct NDC
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)A-S Medication Solutions50090-4508
Budesonide and Formoterol Fumarate DihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)A-S Medication Solutions50090-6382
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)A-S Medication Solutions50090-4509
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)A-S Medication Solutions50090-4510
Budesonide and Formoterol Fumarate DihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)Sportpharm LLC85766-113
Budesonide and Formoterol Fumarate DihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)Sportpharm LLC85766-114
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)AstraZeneca Pharmaceuticals LP0186-0370
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)A-S Medication Solutions50090-1403
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)AstraZeneca Pharmaceuticals LP0186-0372
Budesonide and Formoterol Fumarate DihydrateBudesonide 160 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)AstraZeneca Pharmaceuticals LP0310-7370
Budesonide and Formoterol Fumarate DihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)AstraZeneca Pharmaceuticals LP0310-7372
Symbicortbudesonide and formoterol fumarate dihydrateBudesonide 80 ug/1; Formoterol fumarate 4.5 ug/1AerosolRespiratory (Inhalation)Sportpharm LLC85766-184

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