DOCOSANOL
- Product NDC
- 61269-989
- 11-digit product format
- 612690989
- Labeler code
- 61269
- Product ID
- 61269-989_29a71b87-09b6-46e5-955a-86c63a618e48
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCOSANOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- H2-Pharma, LLC
- Application
- ANDA212385
- Marketing category
- ANDA
- Marketing start
- 2023-07-18
- Substance
- DOCOSANOL
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOCOSANOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCOSANOL | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9G1OE216XY |
| Rxcui | 797534 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61269-989-37 | DOCOSANOL | 2 g in 1 BOTTLE, PUMP | CREAM | 2 | | 1 |
| 61269-989-37 | DOCOSANOL | 1 in 1 PACKAGE | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-989 | DOCOSANOL CREAM [H2-PHARMA, LLC] | 1 | Current NDC, 2 package rows | 20230722_48c029bd-c061-4228-b66f-a70a297185b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 61269-989-37 | 61269098937 | 1 BOTTLE, PUMP in 1 PACKAGE (61269-989-37) / 2 g in 1 BOTTLE, PUMP | 2023-07-18 | No | No | Current |