NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7126Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7126Add 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
50090-7126-050090712600500907126006 POUCH in 1 CARTON (50090-7126-0) / 10 mL in 1 POUCHMarketed from Apr 9, 2024

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 inhalation
Generic name (nonproprietary)
budesonide inhalation
Active ingredients
Budesonide — .5 mg/2mL
Dosage form
Suspension
Route
Respiratory (Inhalation)
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210897
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 50090-7126_f8778e56-3cf8-4dc1-bd31-0aab39627a42SPL ID f8778e56-3cf8-4dc1-bd31-0aab39627a42SPL set ID 87048fa9-3391-4f30-801d-b96ca0132f56RxCUI 351109UNII Q3OKS62Q6X
Pharmacologic class
Corticosteroid

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

N450090712600 followed by a unit qualifier and the quantity

Package 50090-7126-00. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-7126

What is NDC 50090-7126?
50090-7126 is the product NDC for budesonide inhalation, Budesonide .5 mg/2mL suspension, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
budesonide inhalation.
What is the active ingredient?
Budesonide.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for budesonide inhalation?
6 other product NDCs are listed under this name. See all budesonide inhalation NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other budesonide inhalation NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
budesonide inhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Preferred Pharmaceuticals, Inc.68788-850368788-8503-03
Budesonide InhalationbudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)Preferred Pharmaceuticals Inc.68788-842968788-8429-03
Budesonide InhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)American Health Packaging60687-52460687-0524-83
budesonide inhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Lupin Pharmaceuticals, Inc.68180-98468180-0984-30
Budesonide InhalationbudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)Amneal Pharmaceuticals of New York LLC0115-168700115-1687-74
Budesonide InhalationbudesonideBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Amneal Pharmaceuticals of New York LLC0115-168900115-1689-74

Other NDCs under ANDA 210897

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

FDA NDC Directory listings under ANDA 210897
ProductStrengthForm · routeLabelerProduct NDC
Budesonide InhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)American Health Packaging60687-524
budesonide inhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Lupin Pharmaceuticals, Inc.68180-984
budesonide inhalationBudesonide .5 mg/2mLSuspensionRespiratory (Inhalation)Preferred Pharmaceuticals, Inc.68788-8503

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