Prescription drug · ANDA
sodium nitroprusside NDC 14335-131
Sodium nitroprusside 50 mg/2mL · Injection, Solution, Concentrate · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14335-131-01 | 1433501310114335013101 | 1 VIAL in 1 CARTON (14335-131-01) / 2 mL in 1 VIALMarketed from Aug 13, 2024 |
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 — 50 mg/2mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Hainan Poly Pharm. Co., Ltd.NDC labeler code 14335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214199
- Marketing start
- Listing expires
- Other FDA classes
- Vasodilation (Physiologic effect)
- Identifiers
- Product ID 14335-131_1f875458-09fa-7330-e063-6394a90aac33SPL ID 1f875458-09fa-7330-e063-6394a90aac33SPL set ID 1f875445-f8e4-b097-e063-6294a90ad544RxCUI 240793UNII EAO03PE1TCUPC 0314335131019
- 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
N414335013101followed by a unit qualifier and the quantityPackage 14335-0131-01. 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 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 is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside is also indicated for the treatment of acute congestive heart failure.
Excerpt only. Read the full label for complete information.
About NDC 14335-131
- What is NDC 14335-131?
- 14335-131 is the product NDC for sodium nitroprusside, Sodium nitroprusside 50 mg/2mL injection, solution, concentrate, listed with the FDA by Hainan Poly Pharm. Co., Ltd.. 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?
- Hainan Poly Pharm. Co., Ltd., NDC labeler code 14335. 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 .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 |
| Sodium Nitroprusside | Sodium nitroprusside 50 mg/2mL | InjectionIntravenous | Armas Pharmaceuticals Inc. | 72485-105 | 72485-0105-01 |
Other NDCs under ANDA 214199
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 50 mg/2mL | Injection, Solution, ConcentrateIntravenous | Slate Run Pharmaceuticals, LLC | 70436-028 |