Povidone Iodine Prep Solution Sterile
- Product NDC
- 34645-0013
- 11-digit product format
- 346450013
- Labeler code
- 34645
- Product ID
- 34645-0013_085d0195-7031-e123-e063-6294a90ab344
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- POVIDONE-IODINE
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Jianerkang Medical Co., Ltd
- Application
- 505G(a)(3)
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-01
- Substance
- POVIDONE-IODINE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Povidone Iodine Prep Solution Sterile
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POVIDONE-IODINE | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 85H0HZU99M |
| Rxcui | 312564 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 34645-0013-1 | Povidone Iodine Prep Solution Sterile | 30 mL in 1 POUCH | SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 34645-0013 | POVIDONE IODINE PREP SOLUTION STERILE (POVIDONE-IODINE) SOLUTION [JIANERKANG MEDICAL CO., LTD] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231023_95f8489e-05fa-4f0f-acd6-0c426009080e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 34645-0013-1 | 34645001301 | 30 mL in 1 POUCH (34645-0013-1) | 30 ml | 2021-01-01 | 0000-00-00 | No | No | Current |