Methylene blue
- Product NDC
- 0143-9094
- 11-digit product format
- 001439094
- Labeler code
- 0143
- Product ID
- 0143-9094_fd057210-bc2c-44d5-bf5d-b1f0a408a946
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylene Blue
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA216959
- Marketing category
- ANDA
- Marketing start
- 2025-06-05
- 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 |
|---|
| 0143-9094-01 | Methylene blue | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 0143-9094-05 | Methylene blue | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 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 |
|---|
| 0143-9094-01 | 00143909401 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 0143-9094-05 | 00143909405 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0143-9094-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9094-01) | | 2025-06-05 | No | No | Historical |