Prescription drug · BLA
Hemgenix (Etranacogene dezaparvovec) NDC 0053-0110
Kit · CSL Behring
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0053-0110-11 | 00053011011 | 1 KIT in 1 CARTON (0053-0110-11) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01)Marketed from Nov 22, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Hemgenix
- Generic name (nonproprietary)
- etranacogene dezaparvovec
- Dosage form
- Kit
- Labeler
- CSL BehringNDC labeler code 0053
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125772
- Marketing start
- Listing expires
- Identifiers
- Product ID 0053-0110_46103596-b3c5-48d1-9c04-dc7619864ffaSPL ID 46103596-b3c5-48d1-9c04-dc7619864ffaSPL set ID 35b2db65-4c6c-4173-ab56-b2bca69193bdRxCUI 2626772, 2626778, 2626780, 2626781, 2626782, 2626783, 2626784, 2626785, 2626786, 2626787, 2626788, 2626789, 2626790, 2626791, 2626792, 2626793, 2626794, 2626795, 2626796, 2626797, 2626798, 2626799, 2626800, 2626801, 2626802, 2626803, 2626804, 2626805, 2626806, 2626807, 2626808, 2626809, 2626810, 2626811, 2626812, 2626813, 2626814, 2626815, 2626816, 2626817, 2626818, 2626819, 2626820, 2626821, 2626822, 2626823, 2626824, 2626825, 2626829, 2626830, 2626831, 2626832, 2626833, 2626834, 2626835, 2626836, 2626837, 2626838, 2626839, 2626840, 2626843, 2626844, 2626845, 2626846, 2626847, 2626848, 2626849, 2626850, 2626851, 2626852, 2626853, 2626854, 2626855, 2626856, 2626857, 2626858, 2626859, 2626860, 2627141, 2627142
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
N400053011011followed by a unit qualifier and the quantityPackage 00053-0110-11. 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)
HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes. HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes.
Excerpt only. Read the full label for complete information.
About NDC 0053-0110
- What is NDC 0053-0110?
- 0053-0110 is the product NDC for Hemgenix (etranacogene dezaparvovec) kit, listed with the FDA by CSL Behring. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hemgenix (Etranacogene dezaparvovec).
- Who is the labeler?
- CSL Behring, NDC labeler code 0053. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hemgenix?
- 38 other product NDCs are listed under this name. See all Hemgenix NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hemgenix products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0130 | 00053-0130-13 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0380 | 00053-0380-38 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0150 | 00053-0150-15 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0450 | 00053-0450-45 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0220 | 00053-0220-22 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0290 | 00053-0290-29 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0360 | 00053-0360-36 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0200 | 00053-0200-20 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0270 | 00053-0270-27 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0340 | 00053-0340-34 |
Other NDCs under BLA 125772
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0130 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0380 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0150 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0450 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0220 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0290 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0360 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0200 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0270 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0340 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0410 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0180 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0480 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0250 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0320 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0390 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0160 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0460 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0230 |
| Hemgenixetranacogene dezaparvovec | — | Kit | CSL Behring | 0053-0300 |
Showing 20 of 38.