Methylene blue
- Product NDC
- 82449-003
- 11-digit product format
- 824490003
- Labeler code
- 82449
- Product ID
- 82449-003_4a8a9adf-f99b-6054-e063-6294a90ade62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylene Blue
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Steriscience Specialties Private Limited
- Application
- ANDA216955
- Marketing category
- ANDA
- Marketing start
- 2026-01-07
- 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, 2731634 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82449-003-06 | Methylene blue | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 3 |
| 82449-003-06 | Methylene blue | 10 mL in 1 SYRINGE | INJECTION, SOLUTION | 10 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82449-003-06 | 82449000306 | 5 SYRINGE in 1 CARTON (82449-003-06) / 10 mL in 1 SYRINGE | 5 syringe | 2026-01-07 | No | No | Historical |