Prescription drug · ANDA
Methylene Blue NDC 68462-698
Methylene blue 50 mg/10mL · Injection · Intravenous · GLENMARK PHARMACEUTICALS INC., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-698-15 | 68462069815 | 5 VIAL, SINGLE-DOSE in 1 CARTON (68462-698-15) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-698-10)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
- Labeler
- GLENMARK PHARMACEUTICALS INC., USANDC labeler code 68462
- 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 68462-698_eec9bc86-b15b-4c0c-a669-65b03b73da0bSPL ID eec9bc86-b15b-4c0c-a669-65b03b73da0bSPL set ID eec9bc86-b15b-4c0c-a669-65b03b73da0bRxCUI 1788984UNII T42P99266KUPC 0368462698150, 0368462698105
- 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
N468462069815followed by a unit qualifier and the quantityPackage 68462-0698-15. 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.
Excerpt only. Read the full label for complete information.
About NDC 68462-698
- What is NDC 68462-698?
- 68462-698 is the product NDC for Methylene Blue, Methylene blue 50 mg/10mL injection, listed with the FDA by GLENMARK PHARMACEUTICALS INC., USA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylene Blue.
- What is the active ingredient?
- Methylene blue.
- Who is the labeler?
- GLENMARK PHARMACEUTICALS INC., USA, NDC labeler code 68462. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methylene Blue?
- 18 other product NDCs are listed under this name. See all Methylene Blue NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylene Blue products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methylene blue | Methylene blue 10 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2083 | 70710-2083-0170710-2083-05 |
| Methylene blue | Methylene blue 10 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1963 | 70771-1963-0170771-1963-05 |
| Methylene blue | Methylene blue 50 mg/10mL | Injection, SolutionIntravenous | Steriscience Specialties Private Limited | 82449-003 | 82449-0003-06 |
| Methylene Blue | Methylene blue 50 mg/10mL | InjectionIntravenous | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-104 | 82432-0104-02 |
| Methylene Blue | Methylene blue 50 mg/10mL | InjectionIntravenous | XIROMED, LLC | 70700-328 | 70700-0328-24 |
| Methylene blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9094 | 00143-9094-05 |
| Methylene blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2715 | 70121-2715-02 |
| Methylene blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2716 | 70121-2716-02 |
| Methylene blue | Methylene blue 50 mg/10mL | Injection, SolutionIntravenous | Steriscience Specialties Private Limited | 82449-002 | 82449-0002-06 |
| Methylene Blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Nexus Pharmaceuticals, LLC | 14789-119 | 14789-0119-05 |
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 | Chengdu Shuode Pharmaceutical Co., Ltd | 82432-104 |