What is NDC 85972-162?

85972-162 is the product NDC for mycophenolic acid, Mycophenolate sodium 360 mg/1 tablet, delayed release, listed with the FDA by Stellon Biotech Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Stellon Biotech Inc., NDC labeler code 85972. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for mycophenolic acid?

34 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

mycophenolic acid NDC 85972-162 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85972-162Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85972-0162Add 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
85972-162-12	8597201621285972016212	120 TABLET, DELAYED RELEASE in 1 BOTTLE (85972-162-12)Marketed from Sep 11, 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): mycophenolic acid
Generic name (nonproprietary): mycophenolic acid
Active ingredients: Mycophenolate sodium — 360 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Stellon Biotech Inc.NDC labeler code 85972
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211173
Marketing start: Sep 11, 2026
Listing expires: Dec 31, 2027
Identifiers: Product ID 85972-162_255231b8-9564-4542-9449-9dcb8c8dd3e7SPL ID 255231b8-9564-4542-9449-9dcb8c8dd3e7SPL set ID 4b153bb3-fb7a-472d-b73e-e630e50c5633RxCUI 485020, 485023UNII WX877SQI1GUPC 0385972162124, 0385972161127
Pharmacologic class: Antimetabolite Immunosuppressant

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

N485972016212 followed by a unit qualifier and the quantity

Package 85972-0162-12. 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 Feb 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85972-162

What is NDC 85972-162?: 85972-162 is the product NDC for mycophenolic acid, Mycophenolate sodium 360 mg/1 tablet, delayed release, listed with the FDA by Stellon Biotech Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: mycophenolic acid.
What is the active ingredient?: Mycophenolate sodium.
Who is the labeler?: Stellon Biotech Inc., NDC labeler code 85972. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for mycophenolic acid?: 34 other product NDCs are listed under this name. See all mycophenolic acid 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 mycophenolic acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
mycophenolic acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Stellon Biotech Inc.	85972-161	85972-0161-12
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Ascend Laboratories, LLC	67877-928	67877-0928-0567877-0928-1267877-0928-38
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Ascend Laboratories, LLC	67877-929	67877-0929-0567877-0929-1267877-0929-38
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4391	70518-4391-00
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-7372	00904-7372-0400904-7372-61
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Biocon Pharma Inc.	70377-126	70377-0126-11
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Biocon Pharma Inc.	70377-127	70377-0127-11
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Novugen Pharma (USA) LLC.	82293-012	82293-0012-10
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Novugen Pharma (USA) LLC.	82293-013	82293-0013-10
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Aurobindo Pharma Limited	59651-621	59651-0621-08

All 35 mycophenolic acid NDCs

Other NDCs under ANDA 211173

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

FDA NDC Directory listings under ANDA 211173
Product	Strength	Form · route	Labeler	Product NDC
mycophenolic acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	CONCORD BIOTECH LIMITED	68254-5001
mycophenolic acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	CONCORD BIOTECH LIMITED	68254-5002
mycophenolic acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Advagen Pharma Limited	72888-199
mycophenolic acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Advagen Pharma Limited	72888-200
mycophenolic acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Stellon Biotech Inc.	85972-161