PROVAYBLUE
- Product NDC
- 0517-0381
- 11-digit product format
- 005170381
- Labeler code
- 0517
- Product ID
- 0517-0381_420bd985-ac55-44b9-b8a0-a5098220575b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylene blue
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- NDA204630
- Marketing category
- NDA
- Marketing start
- 2016-04-08
- Substance
- METHYLENE BLUE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROVAYBLUE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLENE BLUE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T42P99266K |
| Rxcui | 1788984, 1788989, 2199323, 2199324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0517-0381-01 | PROVAYBLUE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 28 |
| 0517-0381-05 | PROVAYBLUE | 5 in 1 CARTON | INJECTION | 5 | | 28 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0381 | PROVAYBLUE (METHYLENE BLUE) INJECTION [AMERICAN REGENT, INC.] | 27 | Current NDC, Legacy NDC, 2 package rows | 20241222_4f6848e5-35ed-4046-b13c-3032b5ba3232.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 |
|---|
| 0517-0381-01 | 00517038101 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | | Historical |
| 0517-0381-05 | 00517038105 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0381-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-0381-01) | | 2021-12-31 | 0000-00-00 | No | No | Current |