What is NDC 59651-585?

59651-585 is the product NDC for Budesonide, Budesonide .5 mg/2mL suspension, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Budesonide NDC 59651-585 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-585Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0585Add 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
59651-585-30	59651058530	6 POUCH in 1 CARTON (59651-585-30) / 5 AMPULE in 1 POUCH (59651-585-05) / 2 mL in 1 AMPULEMarketed from Nov 29, 2023

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
Generic name (nonproprietary): budesonide
Active ingredients: Budesonide — .5 mg/2mL
Dosage form: Suspension
Route: Respiratory (Inhalation)
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216667
Marketing start: Nov 29, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 59651-585_c70c734f-2431-4414-bb94-4adda4985e5dSPL ID c70c734f-2431-4414-bb94-4adda4985e5dSPL set ID c70c734f-2431-4414-bb94-4adda4985e5dRxCUI 351109UNII Q3OKS62Q6XUPC 0359651585054
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

N459651058530 followed by a unit qualifier and the quantity

Package 59651-0585-30. 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 Dec 2, 2023.

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 59651-585

What is NDC 59651-585?: 59651-585 is the product NDC for Budesonide, Budesonide .5 mg/2mL suspension, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Budesonide.
What is the active ingredient?: Budesonide.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. 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?: 43 other product NDCs are listed under this name. See all Budesonide 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Budesonide	Budesonide .25 mg/2mL	SuspensionRespiratory (Inhalation)	American Health Packaging	60687-889	60687-0889-83
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	REMEDYREPACK INC.	70518-4613	70518-4613-00
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Rugby Laboratories	0536-1456	00536-1456-84
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	49035-703	49035-0703-01
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	Walgreens	0363-0048	00363-0048-01
Budesonide	Budesonide 32 ug/1	Spray, MeteredNasal	CVS Pharmacy	69842-001	69842-0001-01
Budesonide	Budesonide 3 mg/1	Capsule, Delayed releaseOral	Amneal Pharmaceuticals of New York LLC	53746-778	53746-0778-10
Budesonide	Budesonide .25 mg/2mL	InhalantRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-638	64980-0638-03
Budesonide	Budesonide .5 mg/2mL	InhalantRespiratory (Inhalation)	Rising Pharma Holdings, Inc.	64980-639	64980-0639-03
budesonide	Budesonide 3 mg/1	Capsule, Coated pelletsOral	Major Pharmaceuticals	0904-7313	00904-7313-10

All 44 Budesonide NDCs