Prescription drug · NDA
Aubagio (Teriflunomide) NDC 58468-0211
Teriflunomide 7 mg/1 · Tablet, Film coated · Oral · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0211-2 | 58468021102 | 1 BLISTER PACK in 1 CARTON (58468-0211-2) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2013 | |
| 58468-0211-3 | 58468021103 | 1 BLISTER PACK in 1 CARTON (58468-0211-3) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 1, 2013 · Sample package | |
| 58468-0211-4 | 58468021104 | 1 BOTTLE in 1 CARTON (58468-0211-4) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Mar 28, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Aubagio
- Generic name (nonproprietary)
- teriflunomide
- Active ingredients
- Teriflunomide — 7 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202992
- Marketing start
- Listing expires
- Other FDA classes
- Dihydroorotate Dehydrogenase Inhibitors (Mechanism)
- Identifiers
- Product ID 58468-0211_fafc0928-a014-4dfc-8f46-e0d8aa6690bcSPL ID fafc0928-a014-4dfc-8f46-e0d8aa6690bcSPL set ID 4650d12c-b9c8-4525-b07f-a2d773eca155RxCUI 1310525, 1310531, 1310533, 1310535UNII 1C058IKG3B
- Pharmacologic class
- Pyrimidine Synthesis Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458468021102followed by a unit qualifier and the quantityPackage 58468-0211-02. 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)
AUBAGIO ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0211
- What is NDC 58468-0211?
- 58468-0211 is the product NDC for Aubagio (teriflunomide), Teriflunomide 7 mg/1 tablet, film coated, listed with the FDA by Genzyme Corporation. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aubagio (Teriflunomide).
- What is the active ingredient?
- Teriflunomide.
- Who is the labeler?
- Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aubagio?
- 1 other product NDC are listed under this name. See all Aubagio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aubagio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aubagioteriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-0210 | 58468-0210-0158468-0210-0358468-0210-04 |
Other NDCs under NDA 202992
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 |
|---|---|---|---|---|
| Aubagioteriflunomide | Teriflunomide 14 mg/1 | Tablet, Film coatedOral | Genzyme Corporation | 58468-0210 |