Prescription drug · NDA
Provayblue (methylene blue) NDC 0517-0371
Methylene blue 5 mg/mL · Injection · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-0371-05 | 00517037105 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-0371-05) / 2 mL in 1 VIAL, SINGLE-DOSE (0517-0371-01)Marketed from Dec 31, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Provayblue
- Generic name (nonproprietary)
- methylene blue
- Active ingredients
- Methylene blue — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- American Regent, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204630
- Marketing start
- Listing expires
- Other FDA classes
- Oxidation-Reduction Activity (Mechanism)
- Identifiers
- Product ID 0517-0371_420bd985-ac55-44b9-b8a0-a5098220575bSPL ID 420bd985-ac55-44b9-b8a0-a5098220575bSPL set ID 4f6848e5-35ed-4046-b13c-3032b5ba3232RxCUI 1788984, 1788989, 2199323, 2199324UNII T42P99266K
- 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
N400517037105followed by a unit qualifier and the quantityPackage 00517-0371-05. 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)
PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204630
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Provaybluemethylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | American Regent, Inc. | 0517-0125 |
| Provaybluemethylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | American Regent, Inc. | 0517-0374 |
| Provaybluemethylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | American Regent, Inc. | 0517-0381 |