Prescription drug · ANDA
Sodium nitroprusside NDC 67457-839
Sodium nitroprusside 25 mg/mL · Injection, Solution, Concentrate · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-839-02 | 6745708390267457083902 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-839-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 10, 2018 |
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)
- Sodium nitroprusside
- Generic name (nonproprietary)
- sodium nitroprusside
- Active ingredients
- Sodium nitroprusside — 25 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210763
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 67457-839_c4d84a94-85c2-4073-b1aa-c4f4b21a500aSPL ID c4d84a94-85c2-4073-b1aa-c4f4b21a500aSPL set ID 6fbfb86c-da8d-4741-b1e0-7000e2bbad5fRxCUI 240793UNII EAO03PE1TC
- Pharmacologic class
- Vasodilator
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
N467457083902followed by a unit qualifier and the quantityPackage 67457-0839-02. 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)
INDICATIONS AND USAGE Sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure.
Excerpt only. Read the full label for complete information.
About NDC 67457-839
- What is NDC 67457-839?
- 67457-839 is the product NDC for Sodium nitroprusside, Sodium nitroprusside 25 mg/mL injection, solution, concentrate, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium nitroprusside.
- What is the active ingredient?
- Sodium nitroprusside.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium nitroprusside?
- 16 other product NDCs are listed under this name. See all Sodium nitroprusside NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium nitroprusside products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Nitroprusside | Sodium nitroprusside 50 mg/2mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Inc., | 75907-290 | 75907-0290-11 |
| Sodium Nitroprusside | Sodium nitroprusside 50 mg/2mL | InjectionIntravenous | Caplin Steriles Limited | 65145-101 | 65145-0101-01 |
| sodium nitroprusside | Sodium nitroprusside 50 mg/2mL | Injection, Solution, ConcentrateIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-131 | 14335-0131-01 |
| Sodium Nitroprusside | Sodium nitroprusside .2 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-132 | 14335-0132-01 |
| Sodium Nitroprusside | Sodium nitroprusside .2 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-133 | 14335-0133-01 |
| Sodium Nitroprusside | Sodium nitroprusside .5 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-134 | 14335-0134-01 |
| Sodium Nitroprusside | Sodium nitroprusside 50 mg/2mL | InjectionIntravenous | BE Pharmaceuticals Inc. | 71839-120 | 71839-0120-01 |
| Sodium Nitroprusside | Sodium nitroprusside 50 mg/2mL | InjectionIntravenous | AuroMedics Pharma LLC | 55150-320 | 55150-0320-01 |
| sodium nitroprusside | Sodium nitroprusside 50 mg/2mL | Injection, Solution, ConcentrateIntravenous | Slate Run Pharmaceuticals, LLC | 70436-028 | 70436-0028-80 |
| Sodium nitroprusside | Sodium nitroprusside 25 mg/mL | Injection, Solution, ConcentrateIntravenous | Mylan Institutional LLC | 67457-999 | 67457-0999-02 |
Other NDCs under ANDA 210763
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 |
|---|---|---|---|---|
| Sodium nitroprusside | Sodium nitroprusside 25 mg/mL | Injection, Solution, ConcentrateIntravenous | Mylan Institutional LLC | 67457-999 |