NDC codes

FDA NDC Directory
Product NDC (as listed)67877-426Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0426Add 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
67877-426-056787704260567877042605500 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-05)Marketed from Sep 24, 2021
67877-426-126787704261267877042612120 TABLET, DELAYED RELEASE in 1 BOTTLE (67877-426-12)Marketed from Sep 24, 2021
67877-426-38678770426386787704263810 BLISTER PACK in 1 CARTON (67877-426-38) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67877-426-33)Marketed from Sep 24, 2021

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 — 180 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208315
Marketing start
Listing expires
Identifiers
Product ID 67877-426_27fbf61b-de1e-479a-9d04-6dc1d48f3148SPL ID 27fbf61b-de1e-479a-9d04-6dc1d48f3148SPL set ID 2d9975e1-baee-4b0c-83de-8a0a92c5d075RxCUI 485020, 485023UNII WX877SQI1GUPC 0367877427126
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

N467877042605 followed by a unit qualifier and the quantity

Package 67877-0426-05. 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)

• 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 ki…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-426

What is NDC 67877-426?
67877-426 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 180 mg/1 tablet, delayed release, listed with the FDA by Ascend Laboratories, LLC. It has 3 package NDCs, 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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 208315

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

FDA NDC Directory listings under ANDA 208315
ProductStrengthForm · routeLabelerProduct NDC
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralMajor Pharmaceuticals0904-7372
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralA-S Medication Solutions50090-6492
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralAscend Laboratories, LLC67877-427
Mycophenolic AcidMycophenolate sodium 180 mg/1Tablet, Delayed releaseOralAscend Laboratories, LLC67877-928
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralAscend Laboratories, LLC67877-929
Mycophenolic AcidMycophenolate sodium 360 mg/1Tablet, Delayed releaseOralREMEDYREPACK INC.70518-4391

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