NDC codes

FDA NDC Directory
Product NDC (as listed)49771-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49771-0002Add 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
49771-002-03497710002033 TRAY in 1 CARTON (49771-002-03) / 1 KIT in 1 TRAY (49771-002-01) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 SYRINGE, GLASSMarketed from Feb 8, 2012

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)
Mitosol
Generic name (nonproprietary)
mitomycin
Dosage form
Kit
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022572
Marketing start
Listing expires
Identifiers
Product ID 49771-002_ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7SPL ID ffbaf9a3-07ba-4b4f-ad79-d0ec5dcf84d7SPL set ID 244002c6-c61d-43fe-9326-072797113979RxCUI 1244553, 1244558

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.

NDC on a medical claim

N449771000203 followed by a unit qualifier and the quantity

Package 49771-0002-03. 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 .

Indications (excerpt from the label)

Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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