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Neomycin and Polymyxin B Sulfates 40 mg/mL; 200000 [USP'U]/mL Solution — NDC 39822-1220-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Neomycin and Polymyxin B Sulfates 40 mg/mL; 200000 [USP'U]/mL Solution — NDC 39822-1220-1 (Billing 39822-1220-01)

by XGen Pharmaceuticals DJB, Inc. · 1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS

This is a package of Neomycin and Polymyxin B Sulfates 40 mg/mL; 200000 [USP'U]/mL Solution from XGen Pharmaceuticals DJB, Inc., marketed since Jan 2006 and currently FDA-listed. It is this product's only package size.

NDC 39822-1220-01
🏷️ FDA NDC (as labeled) 39822-1220-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 39822-1220-1
Product NDC 39822-1220
11-digit billing NDC 39822122001
NCPDP billing unit ML — per mL (volume)
RxCUI 314124
UNII 057Y626693, 19371312D4
UPC 0339822120154, 0339822122011
Application # ANDA065108
SPL Set ID a2f47d77-efd3-4c84-a364-08fb6d9978eb
Established class (EPC) Aminoglycoside Antibacterial; Polymyxin-class Antibacterial
Chemical class Aminoglycosides; Polymyxins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-01-31
Route IRRIGATION
Dosage form SOLUTION
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 56701002102000
GPI class Neomycin-Polymyxin B GU
GCN Seq No 009833
GCN 89680
HICL code 003369
Ingredient (HICL) Neomycin Sulf/Polymyxin B Sulf
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8F
Therapeutic class — specific (HIC3) Irrigants
AHFS code 84:04.04.00
AHFS class Antibacterials (84:04)
FDB label name NEOMY-POLYMYXIN B 40 MG/ML VL
FDB brand name Neomycin-Polymyxin B
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009833
  • GCN: 89680
  • GPI-14 (Medi-Span): 56701002102000
  • HICL (First Databank): 003369
  • AHFS class code: 84:04.04.00
  • RxCUI (RxNorm): 314124
Why two NDCs? The FDA registers this code as 39822-1220-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 39822-1220-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminoglycoside Antibacterial class.

Pharmacologic class Aminoglycoside Antibacterial
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Antibiotics, Antiinfectives
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NEOMY-POLYMYXIN B 40 MG/ML VL Ingredient Neomycin Sulf/Polymyxin B Sulf

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $8.94 $178.89 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
39822-1220-01 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 20 mL in 1 VIAL, GLASS 2006-01-31 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Neomycin and Polymyxin B Sulfates 40 mg/mL; 200000 [USP'U]/mL 39822-1201-02 XGen 10 ampules — — Discontinued —
Neomycin and Polymyxin B Sulfates 40 mg/mL; 200000 [USP'U]/mLthis 39822-1220-01 XGen 1 vial — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2006
On the market since
Jan 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerXGen Pharmaceuticals DJB, Inc.
Application holderXGEN PHARMACEUTICALS DJB INC
FDA applicationANDA065108 (ANDA)
Labeler code39822
First marketedJan 2006
Product typeHuman Prescription Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 169 words ▾

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 use of closed systems with indwelling catheters has been shown to reduce the risk of infection. A three-way closed catheter system with constant neomycin-polymyxin B bladder rinse is indicated to prevent the development of infection while using indwelling catheters.

If uropathogens are isolated, they should be identified and tested for susceptibility so that appropriate antimicrobial therapy for systemic use can be initiated.

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION This preparation is specifically designed for use with “three-way catheters or with other catheter systems permitting continuous irrigation of the urinary bladder. The usual irrigation dose is 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation a day for up to 10 days. Using strict aseptic techniques, 1 mL of Neomycin and Polymyxin B Sulfates Solution for Irrigation should be added to a 1,000-mL container of isotonic saline solution.

This container should then be connected to the inflow lumen of the “three-way” catheter which has been inserted with full aseptic precautions; use of a sterile lubricant is recommended during insertion of the catheter. The outflow lumen should be connected, via a sterile disposable plastic tube, to a disposable plastic collection bag. Stringent procedures, such as taping the inflow and outflow junction at the catheter, should be observed when necessary to insure the junctional integrity of the system.

For most patients, the inflow rate of the 1,000-mL saline solution of neomycin and polymyxin B should be adjusted to a slow drip to deliver about 1,000 mL every 24 hours. If the patient’s urine output exceeds 2 liters per day, it is recommended that the inflow rate be adjusted to deliver 2,000 mL of the solution in a 24-hour period. It is important that the rinse of the bladder be continuous ; the inflow or rinse solution should not be interrupted for more than a few minutes.

Preparation of the irrigation solution should be performed with strict aseptic techniques. The prepared solution should be stored at 4°C, and should be used within 48 hours following preparation to reduce the risk of contamination with resistant microorganisms.

⛔ Contraindications 50 words ▾

CONTRAINDICATIONS Hypersensitivity to neomycin, the polymyxins, or any ingredient in the solution is a contraindication to its use. A history of hypersensitivity or serious toxic reaction to an aminoglycoside may also contraindicate the use of any other aminoglycoside because of the known cross-sensitivity of patients to drugs of this class.

⚠️ Warnings ~2 min read ▾

WARNINGS PROPHYLACTIC BLADDER CARE WITH NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION FOR IRRIGATION SHOULD NOT BE GIVEN WHERE THERE IS A POSSIBILITY OF SYSTEMIC ABSORPTION. NEOMYCIN AND POLYMYXIN B SULFATES SOLUTION SHOULD NOT BE USED FOR IRRIGATION OTHER THAN FOR THE URINARY BLADDER. Systemic absorption after topical application of neomycin to open wounds, burns, and granulating surfaces is significant and serum concentrations comparable to and often higher than those attained following oral and parenteral therapy have been reported.

Absorption of neomycin from the denuded bladder surface has been reported. However, the likelihood of toxicity following topical irrigation of the intact urinary bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation is low since no appreciable amounts of these antibiotics enter the systemic circulation by this route if irrigation does not exceed 10 days. Neomycin and Polymyxin B Sulfates Solution for Irrigation is intended for continuous prophylactic irrigation of the lumen of the intact urinary bladder of patients with indwelling catheters.

Patients should be under constant supervision by a physician. Irrigation should be avoided in patients with defects in the bladder mucosa or bladder wall, such as vesical rupture, or in association with operative procedures on the bladder wall, because of the risk of toxicity due to systemic absorption following diffusion into absorptive tissues and spaces. When absorbed, neomycin and polymyxin B are nephrotoxic antibiotics, and the nephrotoxic potentials are additive.

In addition, both antibiotics, when absorbed, are neurotoxins: neomycin can destroy fibers of the acoustic nerve causing permanent bilateral deafness; neomycin and polymyxin B are additive in their neuromuscular blocking effects, not only in terms of potency and duration, but also in terms of characteristics of the blocks produced. Aminoglycosides, when absorbed, can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total, irreversible, bilateral, congenital deafness in children whose mothers received streptomycin during pregnancy.

Although serious side effects have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. If Neomycin and Polymyxin B Sulfates Solution for Irrigation is used during pregnancy, the patient should be apprised of the potential hazard to the fetus (see PRECAUTIONS ).

🤒 Adverse Reactions 76 words ▾

ADVERSE REACTIONS Neomycin occasionally causes skin sensitization when applied topically; however, topical application to mucus membranes rarely results in local or systemic hypersensitivity reactions. Irritation of the urinary bladder mucosa has been reported. Signs of ototoxicity and nephrotoxicity have been reported following parenteral use of drugs and following the oral and topical use of neomycin (see WARNINGS ).

To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 9 words ▾

Pregnancy Teratogenic Effects Pregnancy Category D. See WARNINGS section.

🧒 Pediatric Use 12 words ▾

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧬 Clinical Pharmacology 142 words ▾

CLINICAL PHARMACOLOGY After prophylactic irrigation of the intact urinary bladder, neomycin and polymyxin B are absorbed in clinically insignificant quantities. A neomycin serum level of 0.1 mcg/mL was observed in three of 33 patients receiving the rinse solution. This level is well below that which has been associated with neomycin-induced toxicity.

When used topically, polymyxin B sulfate and neomycin are rarely irritating. Microbiology The prepared Neomycin and Polymyxin B Sulfates Solution for Irrigation is bactericidal. The aminoglycosides act by inhibiting normal protein synthesis in susceptible microorganisms.

Polymyxins increase the permeability of bacterial cell wall membranes. The solution is active in vitro against: Escherichia coli Staphylococcus aureus Haemophilus influenzae Klebsiella and Enterobacter species Neisseria species, and Pseudomonas aeruginosa It is not active in vitro against Serratia marcescens and streptococci. Bacterial resistance may develop following the use of the antibiotics in the catheter-rinse solution.

📦 How Supplied / Storage and Handling 66 words ▾

HOW SUPPLIED Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP is supplied as: 1 mL/ampul (NDC 39822-1201-1) in boxes of 50 (NDC 39822-1201-5) and 20 mL Multiple Dose Vial in single Vial cartons (NDC 39822-1220-1). Store at 2° to 8°C (36° to 46°F). Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814 Made in India. Revised: February 2026 204001021 NP-PISG-00 XG DJB RX Only

📋 Description 153 words ▾

DESCRIPTION Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP is a concentrated sterile antibiotic solution to be diluted for urinary bladder irrigation. Each mL contains neomycin sulfate equivalent to 40 mg neomycin base, 200,000 units polymyxin B sulfate, and Water for Injection, inactive ingredient: sulfuric acid. The 20-mL multiple dose vial contains, in addition to the above, 1 mg methylparaben (0.1%) added as a preservative.

Neomycin sulfate, an antibiotic of the aminoglycoside group, is the sulfate salt of neomycin B and C produced by Streptomyces fradiae. It has a potency equivalent to not less than 600 mcg of neomycin per mg. The structural formulae are: Polymyxin B sulfate, a polypeptide antibiotic, is the sulfate salt of polymyxin B 1 and B 2 produced by the growth of Bacillus polymyxa.

It has a potency of not less than 6,000 polymyxin B units per mg. The structural formulae are: C:\Documents and Settings\junem.X-GEN.000\Desktop\01.jpg J:\QA-RA\Regulatory Affairs\June\02.jpg

⚠️ Precautions 168 words ▾

PRECAUTIONS General Ototoxicity, nephrotoxicity, and neuromuscular blockade may occur if Neomycin and Polymyxin B Sulfates Solution for Irrigation ingredients are systemically absorbed (see WARNINGS ). Absorption of neomycin from the denuded bladder surface has been reported. Patients with impaired renal function, infants, dehydrated patients, elderly patients, and patients receiving high doses of prolonged treatment are especially at risk for the development of toxicity.

Irrigation of the bladder with Neomycin and Polymyxin B Sulfates Solution for Irrigation may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs. The safety and effectiveness of the preparation for use in the care of patients with recent lower urinary tract surgery have not been established.

Urine specimens should be collected during prophylactic bladder care for urinalysis, culture, and susceptibility testing. Positive cultures suggest the presence or organisms which are resistant to the bladder rinse antibiotics. Pregnancy Teratogenic Effects Pregnancy Category D.

See WARNINGS section. Pediatric Use Safety and effectiveness in pediatric patients have not been established.

📄 Package Label / Principal Display Panel 110 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 39822-1201-1 Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP STERILE 1 mL XGen Pharmaceuticals DJB, Inc. FOR IRRIGATION USE ONLY NOT FOR INJECTION NDC 39822-1201-5 Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP STERILE 50 Ampul Carton XGen Pharmaceuticals DJB, Inc. FOR IRRIGATION USE ONLY NOT FOR INJECTION NDC 39822-1220-1 Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP STERILE 20 mL XGen Pharmaceuticals DJB, Inc.

FOR IRRIGATION USE ONLY NOT FOR INJECTION NDC 39822-1220-1 Neomycin and Polymyxin B Sulfates Solution for Irrigation, USP STERILE Single Vial Carton XGen Pharmaceuticals DJB, INC. FOR IRRIGATION USE ONLY NOT FOR INJECTION neo-poly-ampul-label neo-poly0carton050-ampuls_page_1 neo-poly-vial-label neo-poly-vial-carton_Page_1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2025 · 1 quarter of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
19
Units reimbursed last 4 qtrs
13
Gross reimbursed last 4 qtrs
$116.28
Avg / prescription
$6.12
Avg / unit
$8.8899
Latest quarter Q1 2025
19Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 19 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: 13 units · 0.4 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.40.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Utah 0.4 /100k
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by XGen Pharmaceuticals DJB, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
XGen Pharmaceuticals DJB, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 39822-1201-02 · XGen 39822-1800-01 · XGen →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.