What is NDC 68180-984?

68180-984 is the product NDC for budesonide inhalation, Budesonide .5 mg/2mL suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

budesonide inhalation NDC 68180-984

NDC codes

FDA NDC Directory

Product NDC (as listed)68180-984Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68180-0984Add 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 NDC	11-digit (billing)	Package	Copy
68180-984-30	6818009843068180098430	6 POUCH in 1 CARTON (68180-984-30) / 5 AMPULE in 1 POUCH / 2 mL in 1 AMPULEMarketed from May 21, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Lupin Pharmaceuticals, Inc.NDC labeler code 68180
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210897
Marketing start: May 21, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68180-984_3315e8ee-f729-4dab-86e4-349ab1c9c9caSPL ID 3315e8ee-f729-4dab-86e4-349ab1c9c9caSPL set ID 944cbb7c-b41d-4a6d-8a93-2e646365c982RxCUI 351109UNII Q3OKS62Q6XUPC 0368180984054
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

N468180098430 followed by a unit qualifier and the quantity

Package 68180-0984-30. 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 Jan 23, 2025. 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 68180-984

What is NDC 68180-984?: 68180-984 is the product NDC for budesonide inhalation, Budesonide .5 mg/2mL suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. 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?: Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
budesonide inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	Preferred Pharmaceuticals, Inc.	68788-8503	68788-8503-03
Budesonide Inhalationbudesonide	Budesonide .25 mg/2mL	SuspensionRespiratory (Inhalation)	Preferred Pharmaceuticals Inc.	68788-8429	68788-8429-03
Budesonide Inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	American Health Packaging	60687-524	60687-0524-83
budesonide inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	A-S Medication Solutions	50090-7126	50090-7126-00
Budesonide Inhalationbudesonide	Budesonide .25 mg/2mL	SuspensionRespiratory (Inhalation)	Amneal Pharmaceuticals of New York LLC	0115-1687	00115-1687-74
Budesonide Inhalationbudesonide	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	Amneal Pharmaceuticals of New York LLC	0115-1689	00115-1689-74

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
Product	Strength	Form · route	Labeler	Product NDC
budesonide inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	A-S Medication Solutions	50090-7126
Budesonide Inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	American Health Packaging	60687-524
budesonide inhalation	Budesonide .5 mg/2mL	SuspensionRespiratory (Inhalation)	Preferred Pharmaceuticals, Inc.	68788-8503