Sofdra
- Product NDC
- 83723-010
- 11-digit product format
- 837230010
- Labeler code
- 83723
- Product ID
- 83723-010_3f660131-556e-fa6f-e063-6294a90a3dec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sofpironium bromide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Botanix SB Inc.
- Application
- NDA217347
- Marketing category
- NDA
- Marketing start
- 2024-08-06
- Substance
- SOFPIRONIUM BROMIDE
- Active strength
- 87 mg/.67mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sofdra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOFPIRONIUM BROMIDE | 87 mg/.67mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7B2Y1932XU |
| Rxcui | 2689326, 2689332 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83723-010-50 | Sofdra | 1 in 1 CARTON | GEL | 1 | | 6 |
| 83723-010-50 | Sofdra | 50 mL in 1 BOTTLE | GEL | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83723-010 | SOFDRA (SOFPIRONIUM BROMIDE) GEL [BOTANIX SB INC.] | 5 | Current NDC, 2 package rows | 20240828_78f86f4f-658c-468b-bd54-49182ddcc7ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83723-010-50 | 83723001050 | 1 BOTTLE in 1 CARTON (83723-010-50) / 50 mL in 1 BOTTLE | 1 bottle | 2024-08-06 | No | No | Historical |