METHYLENE BLUE
- Product NDC
- 68462-698
- 11-digit product format
- 684620698
- Labeler code
- 68462
- Product ID
- 68462-698_eec9bc86-b15b-4c0c-a669-65b03b73da0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLENE BLUE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- GLENMARK PHARMACEUTICALS INC., USA
- Application
- ANDA219550
- Marketing category
- ANDA
- Marketing start
- 2025-12-23
- Substance
- METHYLENE BLUE
- Active strength
- 50 mg/10mL
- Pharmacologic classes
- Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METHYLENE BLUE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLENE BLUE | 50 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T42P99266K |
| Rxcui | 1788984 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-698-10 | METHYLENE BLUE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 1 |
| 68462-698-15 | METHYLENE BLUE | 5 in 1 CARTON | INJECTION | 5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-698-10 | 68462069810 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 68462-698-15 | 68462069815 | 5 VIAL, SINGLE-DOSE in 1 CARTON (68462-698-15) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10) | | 2025-12-23 | No | No | Current |