NDC codes

FDA NDC Directory
Product NDC (as listed)60687-438Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0438Add 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
60687-438-016068704380160687043801100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-438-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-438-11)Marketed from Jun 14, 2019

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
Active ingredients
Mycophenolate mofetil — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090456
Marketing start
Listing expires
Identifiers
Product ID 60687-438_45762f11-5cf6-b346-e063-6394a90a6199SPL ID 45762f11-5cf6-b346-e063-6394a90a6199SPL set ID 8015f042-54fb-4a7a-a10b-6219e1a450c8RxCUI 200060UNII 9242ECW6R0
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

N460687043801 followed by a unit qualifier and the quantity

Package 60687-0438-01. 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)

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-438

What is NDC 60687-438?
60687-438 is the product NDC for Mycophenolate mofetil, Mycophenolate mofetil 500 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mycophenolate mofetil.
What is the active ingredient?
Mycophenolate mofetil.
Who is the labeler?
American Health Packaging, NDC labeler code 60687. 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

Other NDCs under ANDA 090456

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

FDA NDC Directory listings under ANDA 090456
ProductStrengthForm · routeLabelerProduct NDC
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7078
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-836
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralStrides Pharma Inc.42543-989
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3571
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralStrides Pharma Science Limited64380-725
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3767
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2767
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4377
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralAvKARE73190-010
Mycophenolate mofetilMycophenolate mofetil 500 mg/1Tablet, Film coatedOralProficient Rx LP82804-033

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