Prescription drug · ANDA
Methylene Blue NDC 82432-104
Methylene blue 50 mg/10mL · Injection · Intravenous · Chengdu Shuode Pharmaceutical Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82432-104-02 | 82432010402 | 5 VIAL, SINGLE-DOSE in 1 CARTON (82432-104-02) / 10 mL in 1 VIAL, SINGLE-DOSE (82432-104-01)Marketed from Dec 23, 2025 |
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 — 50 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219550
- Marketing start
- Listing expires
- Other FDA classes
- Oxidation-Reduction Activity (Mechanism)
- Identifiers
- Product ID 82432-104_496e0d21-41a6-070e-e063-6394a90a567fSPL ID 496e0d21-41a6-070e-e063-6394a90a567fSPL set ID fe47491d-810e-466a-aab2-aa92756492baRxCUI 1788984UNII 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
N482432010402followed by a unit qualifier and the quantityPackage 82432-0104-02. 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)
1. INDICATIONS AND USAGE Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Methylene blue injection (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219550
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 |
|---|---|---|---|---|
| Methylene Blue | Methylene blue 50 mg/10mL | InjectionIntravenous | GLENMARK PHARMACEUTICALS INC., USA | 68462-698 |