Prescription drug · ANDA
Neomycin and Polymyxin B Sulfates NDC 39822-1201
Neomycin sulfate 40 mg/mL; Polymyxin b sulfate 200000 [USP'U]/mL · Solution · Irrigation · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-1201-5 | 3982212010539822120105 | 50 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
N439822120105followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Neomycin and Polymyxin B Sulfates products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Neomycin and Polymyxin B Sulfates | Neomycin sulfate 40 mg/mL; Polymyxin b sulfate 200000 [USP'U]/mL | SolutionIrrigation | XGen Pharmaceuticals DJB, Inc. | 39822-1220 | 39822-1220-01 |