Anagen Topical Solution
- Product NDC
- 85475-001
- 11-digit product format
- 854750001
- Labeler code
- 85475
- Product ID
- 85475-001_32f49faf-060a-6877-e063-6394a90a140e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ru-58841 5%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- ANAGEN INNOVATION MEDICINE LTD
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-03
- Substance
- RU-58841
- Active strength
- 5 g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Anagen Topical Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RU-58841 | 5 g/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0D8FJQ0ADW |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85475-001-01 | Anagen Topical Solution | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85475-001 | ANAGEN TOPICAL SOLUTION (RU-58841 5%) SOLUTION [ANAGEN INNOVATION MEDICINE LTD] | 3 | Current NDC, 1 package rows | 20250418_31db47da-ca12-a171-e063-6294a90a6726.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85475-001-01 | 85475000101 | 60 mL in 1 BOTTLE (85475-001-01) | 60 ml | 2025-04-03 | No | No | Historical |