NDC codes

FDA NDC Directory
Product NDC (as listed)0781-2067Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-2067Add 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
0781-2067-0100781206701100 CAPSULE in 1 BOTTLE (0781-2067-01)Marketed from Oct 15, 2008
0781-2067-0500781206705500 CAPSULE in 1 BOTTLE (0781-2067-05)Marketed from Oct 15, 2008
0781-2067-7200781206772120 CAPSULE in 1 BOTTLE (0781-2067-72)Marketed from Oct 15, 2008
0781-2067-890078120678912 CAPSULE in 1 CARTON (0781-2067-89)Marketed from Oct 15, 2008

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 250 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065379
Marketing start
Listing expires
Identifiers
Product ID 0781-2067_8d255117-cfa8-4893-8e2e-945eee7b12c4SPL ID 8d255117-cfa8-4893-8e2e-945eee7b12c4SPL set ID 99b2eb58-8d14-48fc-bbe1-aacb711a783eRxCUI 199058, 200060UNII 9242ECW6R0UPC 0307812067017
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

N400781206701 followed by a unit qualifier and the quantity

Package 00781-2067-01. 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)

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