NDC codes

FDA NDC Directory
Product NDC (as listed)51407-591Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0591Add 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
51407-591-015140705910151407059101100 CAPSULE in 1 BOTTLE (51407-591-01)Marketed from Oct 24, 2024

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 — 3 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Golden State Medical Supply, Inc.NDC labeler code 51407
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021324
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 51407-591_46033509-1371-76c5-e063-6294a90abf4dSPL ID 46033509-1371-76c5-e063-6294a90abf4dSPL set ID 263303c2-8e4f-7b6c-e063-6394a90aef9eRxCUI 1244214UNII 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

N451407059101 followed by a unit qualifier and the quantity

Package 51407-0591-01. 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 .

Indications (excerpt from the label)

Budesonide delayed-release capsules are a corticosteroid indicated for: Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, in patients 8 years and older. ( 1.1 ) Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults. ( 1.2 ) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budeso…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51407-591

What is NDC 51407-591?
51407-591 is the product NDC for budesonide, Budesonide 3 mg/1 capsule, listed with the FDA by Golden State Medical Supply, Inc.. 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?
Golden State Medical Supply, Inc., NDC labeler code 51407. 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?
41 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BudesonideBudesonide .25 mg/2mLSuspensionRespiratory (Inhalation)American Health Packaging60687-88960687-0889-83
budesonideBudesonide 3 mg/1Capsule, Coated pelletsOralREMEDYREPACK INC.70518-461370518-4613-00
BudesonideBudesonide 32 ug/1Spray, MeteredNasalRugby Laboratories0536-145600536-1456-84
BudesonideBudesonide 32 ug/1Spray, MeteredNasalWalgreens0363-004800363-0048-01
BudesonideBudesonide 32 ug/1Spray, MeteredNasalEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-70349035-0703-01
BudesonideBudesonide 32 ug/1Spray, MeteredNasalCVS Pharmacy69842-00169842-0001-01
BudesonideBudesonide 3 mg/1Capsule, Delayed releaseOralAmneal Pharmaceuticals of New York LLC53746-77853746-0778-10
BudesonideBudesonide .25 mg/2mLInhalantRespiratory (Inhalation)Rising Pharma Holdings, Inc.64980-63864980-0638-03
BudesonideBudesonide .5 mg/2mLInhalantRespiratory (Inhalation)Rising Pharma Holdings, Inc.64980-63964980-0639-03
budesonideBudesonide 3 mg/1Capsule, Coated pelletsOralMajor Pharmaceuticals0904-731300904-7313-10

All 42 budesonide NDCs

Other NDCs under NDA 021324

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

FDA NDC Directory listings under NDA 021324
ProductStrengthForm · routeLabelerProduct NDC
budesonideBudesonide 3 mg/1CapsuleOralPadagis US LLC0574-9855
budesonideBudesonide 3 mg/1CapsuleOralBryant Ranch Prepack72162-2473

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