NDC codes

FDA NDC Directory
Product NDC (as listed)60687-524Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0524Add 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
60687-524-83606870524836068705248330 POUCH in 1 CARTON (60687-524-83) / 1 AMPULE in 1 POUCH (60687-524-79) / 2 mL in 1 AMPULEMarketed from Jan 6, 2020

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
American Health PackagingNDC labeler code 60687
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 60687-524_3765f418-7255-94d8-e063-6394a90ab595SPL ID 3765f418-7255-94d8-e063-6394a90ab595SPL set ID 45e5f304-1177-42a2-91c9-3ed1a9c9f8e6RxCUI 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

N460687052483 followed by a unit qualifier and the quantity

Package 60687-0524-83. 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 60687-524

What is NDC 60687-524?
60687-524 is the product NDC for Budesonide Inhalation, Budesonide .5 mg/2mL suspension, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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)A-S Medication Solutions50090-712650090-7126-00
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)A-S Medication Solutions50090-7126
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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