What is NDC 16571-723?

16571-723 is the product NDC for Sulfamylon (mafenide acetate), Mafenide acetate 85 mg/g cream, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sulfamylon?

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.

Sulfamylon NDC 16571-723 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-723Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0723Add 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
16571-723-12	16571072312	1 TUBE in 1 CARTON (16571-723-12) / 113.4 g in 1 TUBEMarketed from May 18, 2020
16571-723-48	16571072348	453.6 g in 1 JAR (16571-723-48)Marketed from May 18, 2020
16571-723-60	16571072360	1 TUBE in 1 CARTON (16571-723-60) / 56.7 g in 1 TUBEMarketed from May 18, 2020

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): Sulfamylon
Generic name (nonproprietary): mafenide acetate
Active ingredients: Mafenide acetate — 85 mg/g
Dosage form: Cream
Route: Topical
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016763
Marketing start: May 18, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Methylated Sulfonamides (EXT)
Identifiers: Product ID 16571-723_58d3a059-d175-4740-bf57-f156588c99b5SPL ID 58d3a059-d175-4740-bf57-f156588c99b5SPL set ID 008eaa23-8f19-4e39-85ff-540c1c834a9eRxCUI 201185, 311406UNII RQ6LP6Z0WY
Pharmacologic class: Methylated Sulfonamide Antibacterial

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

N416571072312 followed by a unit qualifier and the quantity

Package 16571-0723-12. 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 Jul 3, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-723

What is NDC 16571-723?: 16571-723 is the product NDC for Sulfamylon (mafenide acetate), Mafenide acetate 85 mg/g cream, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sulfamylon (Mafenide acetate).
What is the active ingredient?: Mafenide acetate.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 16571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sulfamylon?: 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.

Sulfamylon (Mafenide acetate) NDC 16571-723