Prescription drug · NDA
Nulibry (Fosdenopterin hydrobromide) NDC 42358-295
Fosdenopterin hydrobromide 9.5 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Sentynl Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42358-295-01 | 42358029501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (42358-295-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Oct 28, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nulibry
- Generic name (nonproprietary)
- fosdenopterin hydrobromide
- Active ingredients
- Fosdenopterin hydrobromide — 9.5 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sentynl Therapeutics, Inc.NDC labeler code 42358
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214018
- Marketing start
- Listing expires
- Other FDA classes
- Cyclic Pyranopterin Monophosphate (EXT)
- Identifiers
- Product ID 42358-295_cb790c3a-2ee7-4712-8e98-dc3748aad320SPL ID cb790c3a-2ee7-4712-8e98-dc3748aad320SPL set ID 736aeea3-f206-454d-95d0-fd30964e8aabRxCUI 2531292, 2531297UNII X41B5W735T
- Pharmacologic class
- Cyclic Pyranopterin Monophosphate
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
N442358029501followed by a unit qualifier and the quantityPackage 42358-0295-01. 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)
NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. NULIBRY is cyclic pyranopterin monophosphate (cPMP) indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type A. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42358-295
- What is NDC 42358-295?
- 42358-295 is the product NDC for Nulibry (fosdenopterin hydrobromide), Fosdenopterin hydrobromide 9.5 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Sentynl Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nulibry (Fosdenopterin hydrobromide).
- What is the active ingredient?
- Fosdenopterin hydrobromide.
- Who is the labeler?
- Sentynl Therapeutics, Inc., NDC labeler code 42358. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nulibry?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.