Docosanol
- Product NDC
- 0591-2981
- 11-digit product format
- 005912981
- Labeler code
- 0591
- Product ID
- 0591-2981_294a4de8-ef94-4cdc-aa5d-d9683bee59ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA208754
- Marketing category
- ANDA
- Marketing start
- 2019-04-05
- Marketing end
- 2022-10-31
- Substance
- DOCOSANOL
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- No
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCOSANOL | 100 mg/g |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-2981-00 | 00591298100 | 1080 TUBE in 1 BOX (0591-2981-00) / 2 g in 1 TUBE | 1080 tube | 05-APR-19 | | | | Current |
| 0591-2981-35 | 00591298135 | 1 TUBE in 1 PACKAGE (0591-2981-35) > 2 g in 1 TUBE | 1 tube | 2019-04-05 | 2022-10-31 | No | No | Current |