What is NDC 50484-010?

50484-010 is the product NDC for Collagenase Santyl, Collagenase clostridium histolyticum 250 [arb'U]/g ointment, listed with the FDA by SMITH & NEPHEW, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Collagenase clostridium histolyticum.

SMITH & NEPHEW, INC, NDC labeler code 50484. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Collagenase Santyl?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Collagenase Santyl NDC 50484-010 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50484-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50484-0010Add 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 NDC	11-digit (billing)	Package	Copy
50484-010-30	50484001030	1 TUBE in 1 CARTON (50484-010-30) / 30 g in 1 TUBEMarketed from Oct 18, 2006
50484-010-90	50484001090	1 TUBE in 1 CARTON (50484-010-90) / 90 g in 1 TUBEMarketed from Mar 10, 2014

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): Collagenase Santyl
Generic name (nonproprietary): collagenase santyl
Active ingredients: Collagenase clostridium histolyticum — 250 [arb'U]/g
Dosage form: Ointment
Route: Topical
Labeler: SMITH & NEPHEW, INCNDC labeler code 50484
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 101995
Marketing start: Oct 18, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Collagenases (Chemical/Ingredient)
Identifiers: Product ID 50484-010_155959d1-0367-4fb6-8877-29099d08801cSPL ID 155959d1-0367-4fb6-8877-29099d08801cSPL set ID 6b6fbfc6-98fa-46aa-88ef-ab00fbb08ffdRxCUI 309509UNII 9X7O8V25ITUPC 0350484010300
Pharmacologic class: Collagen-specific Enzyme

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450484001030 followed by a unit qualifier and the quantity

Package 50484-0010-30. 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 May 17, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Collagenase Santyl ◊ Ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50484-010

What is NDC 50484-010?: 50484-010 is the product NDC for Collagenase Santyl, Collagenase clostridium histolyticum 250 [arb'U]/g ointment, listed with the FDA by SMITH & NEPHEW, INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Collagenase Santyl.
What is the active ingredient?: Collagenase clostridium histolyticum.
Who is the labeler?: SMITH & NEPHEW, INC, NDC labeler code 50484. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Collagenase Santyl?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.