Prescription drug · BLA
Elevidys (delandistrogene moxeparvovec-rokl) NDC 60923-528
Kit · Intravenous · Sarepta Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60923-528-37 | 60923052837 | 1 KIT in 1 CARTON (60923-528-37) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 37 POUCH in 1 BOX / 1 SWAB in 1 POUCHMarketed from Jun 22, 2023 |
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)
- Elevidys
- Generic name (nonproprietary)
- delandistrogene moxeparvovec-rokl
- Dosage form
- Kit
- Route
- Intravenous
- Labeler
- Sarepta Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125781
- Marketing start
- Listing expires
- Identifiers
- Product ID 60923-528_a96a4f2b-47a9-4175-b3c4-78a0c9350a09SPL ID a96a4f2b-47a9-4175-b3c4-78a0c9350a09SPL set ID 3525abcd-fbd2-46c5-9706-cffdf2e8a361RxCUI 797544, 2641679, 2641685, 2641687, 2641688, 2641689, 2641690, 2641691, 2641692, 2641693, 2641694, 2641695, 2641696, 2641697, 2641698, 2641699, 2641700, 2641701, 2641702, 2641703, 2641704, 2641705, 2641706, 2641707, 2641708, 2641709, 2641710, 2641711, 2641712, 2641713, 2641714, 2641715, 2641716, 2641717, 2641718, 2641719, 2641720, 2641721, 2641722, 2641723, 2641724, 2641725, 2641726, 2641727, 2641728, 2641729, 2641730, 2641731, 2641732, 2641733, 2641734, 2641735, 2641736, 2641737, 2641738, 2641739, 2641740, 2641741, 2641742, 2641743, 2641744, 2641745, 2641746, 2641747, 2641748, 2641750, 2641751, 2641752, 2641753, 2641754, 2641755, 2641756, 2641757, 2641758, 2641759, 2641760, 2641761, 2641762, 2641763, 2641764, 2641765, 2641766, 2641767, 2641768, 2641769, 2641770, 2641771, 2641772, 2641773, 2641774, 2641775, 2641776, 2641777, 2641778, 2641779, 2641780, 2641781, 2641782, 2641783, 2641784, 2641785, 2641786, 2641787, 2641788, 2641789, 2641830, 2641831, 2641832, 2641833, 2641834, 2641835, 2641836, 2641837, 2641838, 2641839, 2641840, 2641841, 2641842, 2641843, 2641844, 2641845, 2641846, 2641847, 2641848, 2641849UPC 0360923501108, 0360923528372, 0360923540497, 0360923521304, 0360923509180, 0360923542514, 0360923541500, 0360923526354, 0360923559680, 0360923544532, 0360923536452, 0360923525340, 0360923547564, 0360923537466, 0360923503126, 0360923502112, 0360923533420, 0360923505144, 0360923514238, 0360923519288, 0360923529386, 0360923550595, 0360923518274, 0360923517260, 0360923527368, 0360923522318, 0360923515242, 0360923553626, 0360923520291, 0360923512210, 0360923555644, 0360923546550, 0360923551608, 0360923524336, 0360923561706, 0360923552612, 0360923513224, 0360923530399, 0360923554630, 0360923543528, 0360923534434, 0360923504130, 0360923548578, 0360923511206, 0360923510193, 0360923507162, 0360923532416, 0360923557662, 0360923535448, 0360923539484, 0360923538470, 0360923549582, 0360923506158, 0360923556658, 0360923545546, 0360923516256, 0360923560693, 0360923558676, 0360923508176, 0360923531402, 0360923523322
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
N460923052837followed by a unit qualifier and the quantityPackage 60923-0528-37. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are ambulatory and have a confirmed mutation in the DMD gene [see Clinical Pharmacology ( 12.2 ), Clinical Studies ( 14 )] . ELEVIDYS is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD) who are ambulatory and have a confirmed mutation in the DMD gene. ( 1 , 12.2 , 14 ) Limitations of Use: ELEVIDYS is not recommended in patients with: Preexisting liver impairment (defined as gamma-glutamyl transferase [GGT] > 2 x upper limit of normal or total bilirubin > the upper lim…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125781
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 |
|---|---|---|---|---|
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-503 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-501 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-502 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-507 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-504 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-505 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-506 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-508 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-509 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-513 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-510 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-511 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-512 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-517 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-514 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-515 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-516 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-520 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-518 |
| Elevidysdelandistrogene moxeparvovec-rokl | — | KitIntravenous | Sarepta Therapeutics, Inc. | 60923-519 |
Showing 20 of 39.
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.