NDC codes

FDA NDC Directory
Product NDC (as listed)62049-286Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62049-0286Add 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
62049-286-0462049028604620490286044 TABLET in 1 CARTON (62049-286-04)Marketed from Nov 25, 2025
62049-286-0562049028605620490286055 TABLET in 1 CARTON (62049-286-05)Marketed from Nov 25, 2025
62049-286-0662049028606620490286066 TABLET in 1 CARTON (62049-286-06)Marketed from Nov 25, 2025
62049-286-0762049028607620490286077 TABLET in 1 CARTON (62049-286-07)Marketed from Nov 25, 2025
62049-286-0862049028608620490286088 TABLET in 1 CARTON (62049-286-08)Marketed from Nov 25, 2025
62049-286-0962049028609620490286099 TABLET in 1 CARTON (62049-286-09)Marketed from Nov 25, 2025
62049-286-10620490286106204902861010 TABLET in 1 CARTON (62049-286-10)Marketed from Nov 25, 2025

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)
Cladribine
Generic name (nonproprietary)
cladribine
Active ingredients
Cladribine — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Genvion CorporationNDC labeler code 62049
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218425
Marketing start
Listing expires
Identifiers
Product ID 62049-286_8a24939c-6118-83ad-5a85-5277500bb20aSPL ID 8a24939c-6118-83ad-5a85-5277500bb20aSPL set ID f1d650a5-4205-720b-f39b-4213277b6612RxCUI 2122634, 2122635, 2122647, 2122649, 2122654, 2122656, 2122658, 2122660UNII 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

N462049028604 followed by a unit qualifier and the quantity

Package 62049-0286-04. 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)

Cladribine tablets are indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remitting disease in adults. Because of its safety profile, use of cladribine tablets 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 Cladribine tablets are not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [ see Warnings and Precautions (5) ]. Cladribine tablets are purine antimetabolite indicated for the treatment of relapsing form of multiple sclerosis (M…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62049-286

What is NDC 62049-286?
62049-286 is the product NDC for Cladribine, Cladribine 10 mg/1 tablet, listed with the FDA by Genvion Corporation. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cladribine.
What is the active ingredient?
Cladribine.
Who is the labeler?
Genvion Corporation, NDC labeler code 62049. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cladribine?
5 other product NDCs are listed under this name. See all Cladribine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cladribine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CladribineCladribine 10 mg/1TabletOralSandoz Inc.0781-820100781-8201-3700781-8201-5100781-8201-68+4 more
CladribineCladribine 10 mg/1TabletOralApotex Corp.60505-479160505-4791-0160505-4791-0460505-4791-05+4 more
CladribineCladribine 1 mg/mLInjection, SolutionIntravenousHisun Pharmaceuticals USA, Inc.42658-01042658-0010-01
CladribineCladribine 1 mg/mLInjectionIntravenousFresenius Kabi USA, LLC63323-14063323-0140-10
CladribineCladribine 1 mg/mLInjectionIntravenousHikma Pharmaceuticals USA Inc.0143-987100143-9871-01

Other NDCs under ANDA 218425

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

FDA NDC Directory listings under ANDA 218425
ProductStrengthForm · routeLabelerProduct NDC
CladribineCladribine 10 mg/1TabletOralApotex Corp.60505-4791

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