What is NDC 70095-008?

70095-008 is the product NDC for Tofacitinib, Tofacitinib citrate 1 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tofacitinib?

39 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Tofacitinib NDC 70095-008 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70095-008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70095-0008Add 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	Copy
70095-008-02	7009500080270095000802	1 BOTTLE in 1 CARTON (70095-008-02) / 240 mL in 1 BOTTLEMarketed from Jun 3, 2026

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): Tofacitinib
Generic name (nonproprietary): tofacitinib
Active ingredients: Tofacitinib citrate — 1 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 70095
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218407
Marketing start: Jun 3, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Janus Kinase Inhibitors (Mechanism)
Identifiers: Product ID 70095-008_5797e124-2294-e27b-e063-6294a90a4277SPL ID 5797e124-2294-e27b-e063-6294a90a4277SPL set ID a764a133-b870-4514-bbee-24d43f8cb7fdRxCUI 2478433UNII O1FF4DIV0DUPC 0370095008015
Pharmacologic class: Janus Kinase 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

N470095000802 followed by a unit qualifier and the quantity

Package 70095-0008-02. 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 Jul 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Tofacitinib oral solution is a Janus kinase (JAK) inhibitor. Tofacitinib oral solution is indicated for the treatment of pediatric patients 2 years of age and older with: Active psoriatic arthritis ( PsA), who have had an inadequate response or intolerance to one or more TNF blockers. Active polyarticular course juvenile idiopathic arthritis (pcJIA), who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use : Use of tofacitinib oral solution for PsA, or pcJIA in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. ( 1.2 , 1.4 ) 1.2 Psoriatic Arthritis Tofacitinib oral solution is indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70095-008

What is NDC 70095-008?: 70095-008 is the product NDC for Tofacitinib, Tofacitinib citrate 1 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tofacitinib.
What is the active ingredient?: Tofacitinib citrate.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 70095. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tofacitinib?: 39 other product NDCs are listed under this name. See all Tofacitinib 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 Tofacitinib NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Tofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-366	72865-0366-1272865-0366-60
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc	72865-367	72865-0367-1272865-0367-60
Tofacitinib	Tofacitinib citrate 1 mg/mL	SolutionOral	Saptalis Pharmaceuticals, LLC.	71656-071	—
Tofacitinib	Tofacitinib citrate 5 mg/1	Tablet, Film coatedOral	AvKARE	73190-100	73190-0100-60
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	AvKARE	73190-101	73190-0101-60
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	73190-102	73190-0102-30
Tofacitinib	Tofacitinib citrate 1 mg/mL	SolutionOral	IPG Pharmaceuticals, Inc	71085-099	71085-0099-24
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Exelan pharmaceuticals,Inc	76282-816	76282-0816-30
Tofacitinib	Tofacitinib citrate 11 mg/1	Tablet, Film coated, Extended releaseOral	Orient Pharma Co., Ltd. Yunlin Plant	76333-111	76333-0111-15
Tofacitinib	Tofacitinib citrate 10 mg/1	Tablet, Film coatedOral	Micro Labs Limited	42571-377	42571-0377-0542571-0377-3042571-0377-60+1 more

All 40 Tofacitinib NDCs