Prescription drug · NDA
Sofdra (Sofpironium bromide) NDC 83723-010
Sofpironium bromide 87 mg/.67mL · Gel · Topical · Botanix SB Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83723-010-50 | 83723001050 | 1 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
N483723001050followed by a unit qualifier and the quantityPackage 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.
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.