Prescription drug · BLA
Zolgensma (Onasemnogene abeparvovec-xioi) NDC 71894-140
Kit · Novartis Innovative Technologies Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71894-140-09 | 71894014009 | 1 KIT in 1 CARTON (71894-140-09) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01)Marketed from May 24, 2019 |
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)
- Zolgensma
- Generic name (nonproprietary)
- onasemnogene abeparvovec-xioi
- Dosage form
- Kit
- Labeler
- Novartis Innovative Technologies Inc.NDC labeler code 71894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125694
- Marketing start
- Listing expires
- Identifiers
- Product ID 71894-140_7039f121-a56c-49ba-bca9-28b7bc6afbcbSPL ID 7039f121-a56c-49ba-bca9-28b7bc6afbcbSPL set ID 68cd4f06-70e1-40d8-bedb-609ec0afa471RxCUI 797544, 2170239, 2170241, 2170244, 2170245, 2170246, 2170247, 2170248, 2170249, 2170250, 2170251, 2170252, 2170253, 2170254, 2170255, 2170256, 2170257, 2170258, 2170259, 2170260, 2170261, 2170262, 2170263, 2170264, 2170265, 2170266, 2170267, 2170270, 2170272, 2170273, 2170274, 2170275, 2170276, 2170278, 2170279, 2170281, 2170282, 2170283, 2170284, 2170288, 2170289, 2170290, 2170291, 2170292, 2170293, 2170294, 2170295, 2170296, 2170297, 2630761, 2630763, 2630765, 2630767, 2630769, 2630771, 2630773, 2630775, 2630777, 2630779, 2630781, 2630783, 2630785, 2630787, 2630790, 2630832, 2630833, 2630839, 2630840, 2630855, 2630856, 2630857, 2630858, 2630859, 2630860, 2630861, 2630862, 2630863, 2630864, 2630865
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
N471894014009followed by a unit qualifier and the quantityPackage 71894-0140-09. 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)
ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Limitations of Use The safety and effectiveness of repeat administration of ZOLGENSMA have not been evaluated [see Adverse Reactions ( 6.2 )] . The use of ZOLGENSMA in patients with advanced SMA (e.g., complete paralysis of limbs, permanent ventilator-dependence) has not been evaluated [see Clinical Studies ( 14 )] . ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than…
Excerpt only. Read the full label for complete information.
About NDC 71894-140
- What is NDC 71894-140?
- 71894-140 is the product NDC for Zolgensma (onasemnogene abeparvovec-xioi) kit, listed with the FDA by Novartis Innovative Technologies Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zolgensma (Onasemnogene abeparvovec-xioi).
- Who is the labeler?
- Novartis Innovative Technologies Inc., NDC labeler code 71894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zolgensma?
- 36 other product NDCs are listed under this name. See all Zolgensma NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zolgensma products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-120 | 71894-0120-02 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-121 | 71894-0121-03 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-122 | 71894-0122-03 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-123 | 71894-0123-03 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-124 | 71894-0124-04 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-125 | 71894-0125-04 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-126 | 71894-0126-04 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-127 | 71894-0127-05 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-128 | 71894-0128-05 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-129 | 71894-0129-05 |
Other NDCs under BLA 125694
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 |
|---|---|---|---|---|
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-122 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-120 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-121 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-126 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-123 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-124 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-125 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-130 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-127 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-128 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-129 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-133 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-131 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-132 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-137 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-134 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-135 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-136 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-141 |
| Zolgensmaonasemnogene abeparvovec-xioi | — | Kit | Novartis Innovative Technologies Inc. | 71894-138 |
Showing 20 of 36.