NDC codes

FDA NDC Directory
Product NDC (as listed)83723-010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83723-0010Add 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 NDC11-digit (billing)PackageCopy
83723-010-50837230010501 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLEMarketed from Aug 6, 2024

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)
Sofdra
Generic name (nonproprietary)
sofpironium bromide
Active ingredients
Sofpironium bromide — 87 mg/.67mL
Dosage form
Gel
Route
Topical
Labeler
Botanix SB Inc.NDC labeler code 83723
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217347
Marketing start
Listing expires
Identifiers
Product ID 83723-010_3f660131-556e-fa6f-e063-6294a90a3decSPL ID 3f660131-556e-fa6f-e063-6294a90a3decSPL set ID 78f86f4f-658c-468b-bd54-49182ddcc7acRxCUI 2689326, 2689332UNII 7B2Y1932XU

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

N483723001050 followed by a unit qualifier and the quantity

Package 83723-0010-50. 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)

SOFDRA is indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older. SOFDRA is an anticholinergic indicated for the treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83723-010

What is NDC 83723-010?
83723-010 is the product NDC for Sofdra (sofpironium bromide), Sofpironium bromide 87 mg/.67mL gel, listed with the FDA by Botanix SB Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sofdra (Sofpironium bromide).
What is the active ingredient?
Sofpironium bromide.
Who is the labeler?
Botanix SB Inc., NDC labeler code 83723. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sofdra?
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.

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