What is NDC 0781-8201?

0781-8201 is the product NDC for Cladribine, Cladribine 10 mg/1 tablet, listed with the FDA by Sandoz Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc., NDC labeler code 0781. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cladribine NDC 0781-8201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-8201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-8201Add 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 NDC	11-digit (billing)	Package
0781-8201-37	0078182013700781820137	9 TABLET in 1 CARTON (0781-8201-37)Marketed from Apr 29, 2026
0781-8201-51	0078182015100781820151	5 TABLET in 1 CARTON (0781-8201-51)Marketed from Apr 29, 2026
0781-8201-68	0078182016800781820168	6 TABLET in 1 CARTON (0781-8201-68)Marketed from Apr 29, 2026
0781-8201-71	0078182017100781820171	7 TABLET in 1 CARTON (0781-8201-71)Marketed from Apr 29, 2026
0781-8201-80	0078182018000781820180	10 TABLET in 1 CARTON (0781-8201-80)Marketed from Apr 29, 2026
0781-8201-85	0078182018500781820185	8 TABLET in 1 CARTON (0781-8201-85)Marketed from Apr 29, 2026
0781-8201-94	0078182019400781820194	4 TABLET in 1 CARTON (0781-8201-94)Marketed from Apr 29, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz Inc.NDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215547
Marketing start: Apr 29, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 0781-8201_549c44bf-67d2-9e14-e063-6294a90a9097SPL ID 549c44bf-67d2-9e14-e063-6294a90a9097SPL set ID e0b363cb-db83-44d6-89d0-1f7176be7459RxCUI 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

N400781820137 followed by a unit qualifier and the quantity

Package 00781-8201-37. 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 Jun 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Cladribine 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 cladribine 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) ]. Cladribine is a purine antimetabolite 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 cladribine is generally recommend…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-8201

What is NDC 0781-8201?: 0781-8201 is the product NDC for Cladribine, Cladribine 10 mg/1 tablet, listed with the FDA by Sandoz Inc.. 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?: Sandoz Inc., NDC labeler code 0781. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cladribine	Cladribine 10 mg/1	TabletOral	Apotex Corp.	60505-4791	60505-4791-0160505-4791-0460505-4791-05+4 more
Cladribine	Cladribine 10 mg/1	TabletOral	Genvion Corporation	62049-286	62049-0286-0462049-0286-0562049-0286-06+4 more
Cladribine	Cladribine 1 mg/mL	Injection, SolutionIntravenous	Hisun Pharmaceuticals USA, Inc.	42658-010	42658-0010-01
Cladribine	Cladribine 1 mg/mL	InjectionIntravenous	Fresenius Kabi USA, LLC	63323-140	63323-0140-10
Cladribine	Cladribine 1 mg/mL	InjectionIntravenous	Hikma Pharmaceuticals USA Inc.	0143-9871	00143-9871-01