Betadine
- Product NDC
- 0065-0411
- 11-digit product format
- 000650411
- Labeler code
- 0065
- Product ID
- 0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- povidone-iodine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- NDA018634
- Marketing category
- NDA
- Marketing start
- 2000-04-01
- Substance
- POVIDONE-IODINE
- Active strength
- 5 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
- Betadine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POVIDONE-IODINE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 85H0HZU99M |
| Rxcui | 312570, 1149663 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-0411-30 | Betadine | 1 in 1 CARTON | SOLUTION | 1 | | 12 |
| 0065-0411-30 | Betadine | 30 mL in 1 BOTTLE | SOLUTION | 30 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| NONOXYNOL-9 | INACTIVE INGREDIENT | 48Q180SH9T | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 4 | |
| POVIDONE-IODINE | ACTIVE INGREDIENT | 85H0HZU99M | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| IODINE | ACTIVE MOIETY | 9679TC07X4 | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| NONOXYNOL-9 | INACTIVE INGREDIENT | 48Q180SH9T | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | BETADINE (POVIDONE-IODINE) SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0411 | BETADINE (POVIDONE-IODINE) SOLUTION [ALCON LABORATORIES, INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20220702_b026de1b-9949-4557-ac49-c7b0038c24cd.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 |
|---|
| 0065-0411-30 | 00065041130 | 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLE | 1 bottle | 2000-04-01 | 0000-00-00 | No | No | Current |