NDC codes

FDA NDC Directory
Product NDC (as listed)60923-552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60923-0552Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
60923-552-61609230552611 KIT in 1 CARTON (60923-552-61) * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 61 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
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 125781
Marketing start
Listing expires
Identifiers
Product ID 60923-552_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.

How CPT relates to drug billing

NDC on a medical claim

N460923055261 followed by a unit qualifier and the quantity

Package 60923-0552-61. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125781

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125781
ProductStrengthForm · routeLabelerProduct NDC
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-503
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-501
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-502
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-507
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-504
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-505
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-506
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-508
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-509
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-513
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-510
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-511
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-512
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-517
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-514
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-515
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-516
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-520
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-518
Elevidysdelandistrogene moxeparvovec-roklKitIntravenousSarepta Therapeutics, Inc.60923-519

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Elevidys (delandistrogene moxeparvovec-rokl) NDC 60923-552 | Med-Code