Prescription drug · UNAPPROVED DRUG OTHER
Methylene Blue NDC 54288-159
Methylene blue 10 mg/mL · Injection · Intravenous · BPI LABS LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-159-05 | 54288015905 | 5 SYRINGE in 1 PACKAGE (54288-159-05) / 2 mL in 1 SYRINGE (54288-159-01)Marketed from May 15, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Methylene Blue
- Generic name (nonproprietary)
- methylene blue
- Active ingredients
- Methylene blue — 10 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- BPI LABS LLC
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Oxidation-Reduction Activity (Mechanism)
- Identifiers
- Product ID 54288-159_e36054e3-076c-46d7-82f1-33b3d9481376SPL ID e36054e3-076c-46d7-82f1-33b3d9481376SPL set ID fbdd583d-45ba-4d42-8c80-9a13b71980b6RxCUI 2637038UNII T42P99266KUPC 0354288159050, 0354288159012
- Pharmacologic class
- Oxidation-Reduction Agent
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N454288015905followed by a unit qualifier and the quantityPackage 54288-0159-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE : Drug-induced methemoglobinemia
Excerpt only. Read the full label for complete information.