Prescription drug · ANDA
Methylene blue NDC 82449-002
Methylene blue 50 mg/10mL · Injection, Solution · Intravenous · Steriscience Specialties Private Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82449-002-06 | 82449000206 | 5 AMPULE in 1 CARTON (82449-002-06) / 10 mL in 1 AMPULE (82449-002-01)Marketed from Feb 28, 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, Solution
- Route
- Intravenous
- Labeler
- Steriscience Specialties Private LimitedNDC labeler code 82449
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216955
- Marketing start
- Listing expires
- Other FDA classes
- Oxidation-Reduction Activity (Mechanism)
- Identifiers
- Product ID 82449-002_4a8a9adf-f99b-6054-e063-6294a90ade62SPL ID 4a8a9adf-f99b-6054-e063-6294a90ade62SPL set ID eb87d31c-3a8e-4089-9693-20bc17279650RxCUI 1788984, 2731634UNII T42P99266KUPC 0382449002013
- 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
N482449000206followed by a unit qualifier and the quantityPackage 82449-0002-06. 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, USP is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Methylene blue injection 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 82449-002
- What is NDC 82449-002?
- 82449-002 is the product NDC for Methylene blue, Methylene blue 50 mg/10mL injection, solution, listed with the FDA by Steriscience Specialties Private Limited. 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?
- Steriscience Specialties Private Limited, NDC labeler code 82449. 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 Lifesciences Limited | 70771-1963 | 70771-1963-0170771-1963-05 |
| Methylene blue | Methylene blue 10 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-2083 | 70710-2083-0170710-2083-05 |
| 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 | GLENMARK PHARMACEUTICALS INC., USA | 68462-698 | 68462-0698-15 |
| 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 5 mg/mL | Injection, SolutionIntravenous | Nexus Pharmaceuticals, LLC | 14789-119 | 14789-0119-05 |
Other NDCs under ANDA 216955
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 | Injection, SolutionIntravenous | Steriscience Specialties Private Limited | 82449-003 |
| Methylene blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2715 |
| Methylene blue | Methylene blue 5 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-2716 |