Prescription drug · NDA
Mavenclad (Cladribine) NDC 44087-4000
Cladribine 10 mg/1 · Tablet · Oral · EMD Serono, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44087-4000-0 | 4408740000044087400000 | 5 BLISTER PACK in 1 CARTON (44087-4000-0) / 2 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-4 | 4408740000444087400004 | 4 BLISTER PACK in 1 CARTON (44087-4000-4) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-5 | 4408740000544087400005 | 5 BLISTER PACK in 1 CARTON (44087-4000-5) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-6 | 4408740000644087400006 | 6 BLISTER PACK in 1 CARTON (44087-4000-6) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-7 | 4408740000744087400007 | 7 BLISTER PACK in 1 CARTON (44087-4000-7) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-8 | 4408740000844087400008 | 8 BLISTER PACK in 1 CARTON (44087-4000-8) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 44087-4000-9 | 4408740000944087400009 | 9 BLISTER PACK in 1 CARTON (44087-4000-9) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 1, 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)
- Mavenclad
- Generic name (nonproprietary)
- cladribine
- Active ingredients
- Cladribine — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EMD Serono, Inc.NDC labeler code 44087
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022561
- Marketing start
- Listing expires
- Identifiers
- Product ID 44087-4000_c9ed888a-183b-45e9-9274-08aad408e926SPL ID c9ed888a-183b-45e9-9274-08aad408e926SPL set ID 9c75e30a-a410-40f1-b653-04d532bd9144RxCUI 2122634, 2122635, 2122641, 2122642, 2122647, 2122648, 2122649, 2122650, 2122654, 2122655, 2122656, 2122657, 2122658, 2122659, 2122660, 2122661UNII 47M74X9YT5
- Pharmacologic class
- Purine Antimetabolite
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
N444087400000followed by a unit qualifier and the quantityPackage 44087-4000-00. 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)
MAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS [see Warnings and Precautions (5) ]. Limitations of Use MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5) ]. MAVENCLAD is a purine antimetabolite indicated for the treatment of relapsing forms of multiple scleros…
Excerpt only. Read the full label for complete information.
About NDC 44087-4000
- What is NDC 44087-4000?
- 44087-4000 is the product NDC for Mavenclad (cladribine), Cladribine 10 mg/1 tablet, listed with the FDA by EMD Serono, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mavenclad (Cladribine).
- What is the active ingredient?
- Cladribine.
- Who is the labeler?
- EMD Serono, Inc., NDC labeler code 44087. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mavenclad?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.