Prescription drug · ANDA
Methylene blue NDC 70710-1837
Methylene blue 5 mg/mL · Injection · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1837-5 | 70710183705 | 5 VIAL in 1 CARTON (70710-1837-5) / 2 mL in 1 VIAL (70710-1837-1)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
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- 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 70710-1837_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
N470710183705followed by a unit qualifier and the quantityPackage 70710-1837-05. 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.
About NDC 70710-1837
- What is NDC 70710-1837?
- 70710-1837 is the product NDC for Methylene blue, Methylene blue 5 mg/mL injection, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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 50 mg/10mL | Injection, SolutionIntravenous | Steriscience Specialties Private Limited | 82449-002 | 82449-0002-06 |
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 10 mg/mL | InjectionIntravenous | Zydus Lifesciences Limited | 70771-1963 |
| Methylene blue | Methylene blue 5 mg/mL | InjectionIntravenous | Zydus Pharmaceuticals USA Inc. | 70710-1838 |
| 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 |