NDC codes

FDA NDC Directory
Product NDC (as listed)54288-141Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54288-0141Add 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
54288-141-0454288014104542880141044 VIAL in 1 CARTON (54288-141-04) / 20 mL in 1 VIALMarketed from Mar 8, 2023

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)
Mycophenolate Mofetil
Generic name (nonproprietary)
mycophenolate mofetil hydrochloride
Active ingredients
Mycophenolate mofetil hydrochloride — 500 mg/20mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
BPI Labs LLCNDC labeler code 54288
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214283
Marketing start
Listing expires
Identifiers
Product ID 54288-141_5256e12d-9172-485c-8126-9f4414375dc2SPL ID 5256e12d-9172-485c-8126-9f4414375dc2
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N454288014104 followed by a unit qualifier and the quantity

Package 54288-0141-04. 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 54288-141

What is NDC 54288-141?
54288-141 is the product NDC for Mycophenolate Mofetil (mycophenolate mofetil hydrochloride), Mycophenolate mofetil hydrochloride 500 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by BPI Labs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mycophenolate Mofetil (Mycophenolate Mofetil hydrochloride).
What is the active ingredient?
Mycophenolate mofetil hydrochloride.
Who is the labeler?
BPI Labs LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mycophenolate Mofetil?
57 other product NDCs are listed under this name. See all Mycophenolate Mofetil 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 Mycophenolate Mofetil NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
mycophenolate mofetilMycophenolate mofetil 250 mg/1CapsuleOralCardinal Health 107, LLC55154-016155154-0161-00
Mycophenolate MofetilMycophenolate mofetil 200 mg/mLPowder, For suspensionOralStrides Pharma Science Limited64380-89964380-0899-00
Mycophenolate MofetilMycophenolate mofetil 200 mg/mLPowder, For suspensionOralQUAGEN PHARMACEUTICALS LLC70752-29470752-0294-60
Mycophenolate MofetilMycophenolate mofetil 200 mg/mLPowder, For suspensionOralNorthStar Rx LLC72603-75172603-0751-01
mycophenolate mofetilMycophenolate mofetil 250 mg/1CapsuleOralMajor Pharmaceuticals0904-746600904-7466-61
Mycophenolate MofetilMycophenolate mofetil 250 mg/1CapsuleOralWuxi Fortune Pharmaceutical Co.,Ltd.65050-207365050-2073-00
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-437770518-4377-00
Mycophenolate mofetilMycophenolate mofetil 250 mg/1CapsuleOralAvKARE73190-00973190-0009-0173190-0009-50
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralAvKARE73190-01073190-0010-0173190-0010-50
mycophenolate mofetilMycophenolate mofetil 250 mg/1CapsuleOralAmerican Health Packaging60687-88560687-0885-01

All 58 Mycophenolate Mofetil NDCs

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