Budesonide Inhalation Suspension (budesonide) NDC 69097-319

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0319Add 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
69097-319-53	69097031953	30 POUCH in 1 CARTON (69097-319-53) / 1 AMPULE in 1 POUCH (69097-319-32) / 2 mL in 1 AMPULEMarketed from Apr 10, 2020
69097-319-87	69097031987	6 POUCH in 1 CARTON (69097-319-87) / 5 AMPULE in 1 POUCH (69097-319-86) / 2 mL in 1 AMPULEMarketed from Nov 16, 2017

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 SuspensionSuffix: Inhalation Suspension
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — .5 mg/2mL
Dosage form: Inhalant
Route: Oral
Labeler: Cipla USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205710
Marketing start: Nov 16, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 69097-319_29644146-4bcf-49d0-80b3-e31f4b3a6f54SPL ID 29644146-4bcf-49d0-80b3-e31f4b3a6f54SPL set ID c52c5382-1400-44b9-95be-a30e1cf706daRxCUI 252559, 349094, 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469097031953 followed by a unit qualifier and the quantity

Package 69097-0319-53. 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 Jun 10, 2026. 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)

Other NDCs under ANDA 205710

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

FDA NDC Directory listings under ANDA 205710
Product	Strength	Form · route	Labeler	Product NDC
Budesonide Inhalation Suspensionbudesonide	Budesonide .5 mg/2mL	InhalantOral	Preferred Pharmaceuticals Inc.	68788-7314
Budesonide Inhalation Suspensionbudesonide	Budesonide .5 mg/2mL	InhalantOral	Exelan Pharmaceuticals, Inc.	76282-641
Budesonide Inhalation Suspensionbudesonide	Budesonide .25 mg/2mL	InhalantOral	Exelan Pharmaceuticals, Inc.	76282-640
Budesonide Inhalation Suspensionbudesonide	Budesonide 1 mg/2mL	InhalantOral	Exelan Pharmaceuticals, Inc.	76282-642
Budesonide Inhalation Suspensionbudesonide	Budesonide .25 mg/2mL	InhalantOral	Cipla USA Inc.	69097-318
Budesonide Inhalation Suspensionbudesonide	Budesonide 1 mg/2mL	InhalantOral	Cipla USA Inc.	69097-321