Prescription drug · ANDA
Methylene blue NDC 70710-1838
Methylene blue 5 mg/mL · Injection · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1838-5 | 70710183805 | 5 VIAL in 1 CARTON (70710-1838-5) / 10 mL in 1 VIAL (70710-1838-1)Marketed from Dec 5, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215636
- Marketing start
- Listing expires
- Other FDA classes
- Oxidation-Reduction Activity (Mechanism)
- Identifiers
- Product ID 70710-1838_9a71c3d4-778d-4566-a060-8ec69cf93871SPL ID 9a71c3d4-778d-4566-a060-8ec69cf93871SPL set ID 8c56fbad-a449-4ed4-a55f-1694e4e8e26aRxCUI 1737852, 1788984, 2199323UNII 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
N470710183805followed by a unit qualifier and the quantityPackage 70710-1838-05. 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)
Methylene blue injection is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. 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 ANDA 215636
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 5 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1837 |
| Methylene blue | Methylene blue 10 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1963 |
| Methylene blue | Methylene blue 10 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2083 |
| Methylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1767 |
| Methylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1768 |