Methylene Blue
- Product NDC
- 15243-344
- 11-digit product format
- 152430344
- Labeler code
- 15243
- Product ID
- 15243-344_4e6a3ce6-7aa3-4480-e063-6294a90a9332
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLENE BLUE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- OLIC (Thailand) Limited
- Application
- ANDA217561
- Marketing category
- ANDA
- Marketing start
- 2025-02-01
- 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
- 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 | 5 mg/mL |
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 |
|---|
| 15243-344-05 | Methylene Blue | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 1 |
| 15243-344-07 | Methylene Blue | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 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 |
|---|
| 15243-344-05 | 15243034405 | 5 VIAL, GLASS in 1 CARTON (15243-344-05) / 10 mL in 1 VIAL, GLASS (15243-344-07) | | 2025-02-01 | No | No | Historical |
| 15243-344-07 | 15243034407 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | Historical |