NDC codes

FDA NDC Directory
Product NDC (as listed)59651-622Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0622Add 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
59651-622-085965106220859651062208120 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-622-08)Marketed from Feb 27, 2024

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
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218603
Marketing start
Listing expires
Identifiers
Product ID 59651-622_c88372f5-7138-434f-b730-5b3b6f86ec4dSPL ID c88372f5-7138-434f-b730-5b3b6f86ec4d
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

N459651062208 followed by a unit qualifier and the quantity

Package 59651-0622-08. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 59651-622

What is NDC 59651-622?
59651-622 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 360 mg/1 tablet, delayed release, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
mycophenolic acidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralStellon Biotech Inc.85972-16185972-0161-12
mycophenolic acidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralStellon Biotech Inc.85972-16285972-0162-12
Mycophenolic AcidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralAscend Laboratories, LLC67877-92867877-0928-0567877-0928-1267877-0928-38
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralAscend Laboratories, LLC67877-92967877-0929-0567877-0929-1267877-0929-38
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-439170518-4391-00
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralMajor Pharmaceuticals0904-737200904-7372-0400904-7372-61
Mycophenolic AcidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralBiocon Pharma Inc.70377-12670377-0126-11
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralBiocon Pharma Inc.70377-12770377-0127-11
Mycophenolic AcidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralNovugen Pharma (USA) LLC.82293-01282293-0012-10
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralNovugen Pharma (USA) LLC.82293-01382293-0013-10

All 35 Mycophenolic Acid NDCs

Other NDCs under ANDA 218603

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

FDA NDC Directory listings under ANDA 218603
ProductStrengthForm · routeLabelerProduct NDC
Mycophenolic AcidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralAurobindo Pharma Limited59651-621

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