NDC codes

FDA NDC Directory
Product NDC (as listed)60505-6129Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-6129Add 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
60505-6129-260505612902605056129021 BOTTLE, SPRAY in 1 BOTTLE, SPRAY (60505-6129-2) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Apr 19, 2016
60505-6129-660505612906605056129062 BOTTLE, SPRAY in 1 CARTON (60505-6129-6) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Apr 19, 2016
60505-6129-760505612907605056129073 BOTTLE, SPRAY in 1 CARTON (60505-6129-7) / 120 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Apr 19, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 32 ug/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078949
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 60505-6129_df59479a-8980-e041-8936-c4fb5926ef88SPL ID df59479a-8980-e041-8936-c4fb5926ef88SPL set ID f1aac35a-bc72-dd68-8179-8661354589cbRxCUI 1797929UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N460505612902 followed by a unit qualifier and the quantity

Package 60505-6129-02. 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)

Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: • nasal congestion • runny nose • itchy nose • sneezing

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60505-6129

What is NDC 60505-6129?
60505-6129 is the product NDC for Budesonide, Budesonide 32 ug/1 spray, metered, listed with the FDA by Apotex Corp.. It has 3 package NDCs, 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?
Apotex Corp., NDC labeler code 60505. 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 ANDA 078949

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

FDA NDC Directory listings under ANDA 078949
ProductStrengthForm · routeLabelerProduct NDC
BudesonideBudesonide 32 ug/1Spray, MeteredNasalWalgreens0363-0048
BudesonideBudesonide 32 ug/1Spray, MeteredNasalRugby Laboratories0536-1112
BudesonideBudesonide 32 ug/1Spray, MeteredNasalRugby Laboratories0536-1456
BudesonideBudesonide 32 ug/1Spray, MeteredNasalEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)49035-703
BudesonideBudesonide 32 ug/1Spray, MeteredNasalCVS Pharmacy69842-001

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