NDC codes

FDA NDC Directory
Product NDC (as listed)39822-1201Labeler and product segments. Claims need a package NDC.
Product NDC at billing width39822-1201Add 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
39822-1201-5398221201053982212010550 AMPULE in 1 CARTON (39822-1201-5) / 1 mL in 1 AMPULEMarketed from Jan 19, 2006

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)
Neomycin and Polymyxin B Sulfates
Generic name (nonproprietary)
neomycin and polymyxin b sulfates
Active ingredients
Neomycin sulfate — 40 mg/mLPolymyxin b sulfate — 200000 [USP'U]/mL
Dosage form
Solution
Route
Irrigation
Labeler
XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065106
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)Polymyxins (Chemical structure)
Identifiers
Product ID 39822-1201_4d508cf6-f6a4-be9f-e063-6394a90af91eSPL ID 4d508cf6-f6a4-be9f-e063-6394a90af91eSPL set ID a2f47d77-efd3-4c84-a364-08fb6d9978ebRxCUI 314124UNII 19371312D4, 057Y626693UPC 0339822120154, 0339822122011
Pharmacologic class
Aminoglycoside Antibacterial; Polymyxin-class Antibacterial

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

N439822120105 followed by a unit qualifier and the quantity

Package 39822-1201-05. 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)

INDICATIONS AND USAGE Neomycin and Polymyxin B Sulfates Solution for Irrigation is indicated for short-term use (up to 10 days) as a continuous irrigant or rinse in the urinary bladder of abacteriuric patients to help prevent bacteriuria and gram-negative rod septicemia associated with the use of indwelling catheters. Since organisms gain entrance to the bladder by way of, through, and around the catheter, significant bacteriuria is induced by bacterial multiplication in the bladder urine, in the mucoid film often present between catheter and urethra, and in other sites. Urinary tract infection may result from the repeated presence in the urine of large numbers of pathogenic bacteria. The us…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 39822-1201

What is NDC 39822-1201?
39822-1201 is the product NDC for Neomycin and Polymyxin B Sulfates, Neomycin sulfate 40 mg/mL; Polymyxin b sulfate 200000 [USP'U]/mL solution, listed with the FDA by XGen Pharmaceuticals DJB, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Neomycin and Polymyxin B Sulfates.
What is the active ingredient?
Neomycin sulfate, Polymyxin b sulfate.
Who is the labeler?
XGen Pharmaceuticals DJB, Inc., NDC labeler code 39822. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Neomycin and Polymyxin B Sulfates?
1 other product NDC are listed under this name. See all Neomycin and Polymyxin B Sulfates 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 Neomycin and Polymyxin B Sulfates NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Neomycin and Polymyxin B SulfatesNeomycin sulfate 40 mg/mL; Polymyxin b sulfate 200000 [USP'U]/mLSolutionIrrigationXGen Pharmaceuticals DJB, Inc.39822-122039822-1220-01

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