Prescription drug · ANDA
Ibuprofen Lysine NDC 39822-1030
Ibuprofen lysine 10 mg/mL · Solution · Intravenous · XGen Pharmaceuticals DJB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 39822-1030-2 | 3982210300239822103002 | 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1)Marketed from Apr 8, 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)
- Ibuprofen Lysine
- Generic name (nonproprietary)
- ibuprofen lysine
- Active ingredients
- Ibuprofen lysine — 10 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- XGen Pharmaceuticals DJB, Inc.NDC labeler code 39822
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202402
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 39822-1030_09c10e65-0cea-3052-e063-6394a90ae199SPL ID 09c10e65-0cea-3052-e063-6394a90ae199SPL set ID 6cfdec66-9483-4abe-98d3-3a7d389cc952RxCUI 1747294UNII N01ORX9D6S
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N439822103002followed by a unit qualifier and the quantityPackage 39822-1030-02. 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)
Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. The clinical trial was conducted among infants with an asymptomatic PDA. However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA. Ibuprofen Lysine Injection is a nonsteroidal anti-inflammatory drug indicated to close a clinically significant patent ductus…
Excerpt only. Read the full label for complete information.
About NDC 39822-1030
- What is NDC 39822-1030?
- 39822-1030 is the product NDC for Ibuprofen Lysine, Ibuprofen lysine 10 mg/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?
- Ibuprofen Lysine.
- What is the active ingredient?
- Ibuprofen lysine.
- 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 Ibuprofen Lysine?
- 1 other product NDC are listed under this name. See all Ibuprofen Lysine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen Lysine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen Lysine | Ibuprofen lysine 10 mg/mL | SolutionIntravenous | Prasco Laboratories | 66993-490 | 66993-0490-36 |