Prescription drug · ANDA
Nitrofurantoin NDC 40032-450
Nitrofurantoin 25 mg/5mL · Suspension · Oral · Novel Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 40032-450-11 | 4003204501140032045011 | 1 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLEMarketed from Sep 8, 2014 |
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)
- Nitrofurantoin
- Generic name (nonproprietary)
- nitrofurantoin
- Active ingredients
- Nitrofurantoin — 25 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Novel Laboratories, Inc.NDC labeler code 40032
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201693
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 40032-450_f62f5875-c0f1-4892-95c4-a811d8b6f1deSPL ID f62f5875-c0f1-4892-95c4-a811d8b6f1deSPL set ID 499f9dfd-b533-4021-a3ed-308f0f956c79RxCUI 311989UNII 927AH8112L
- Pharmacologic class
- Nitrofuran Antibacterial
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N440032045011followed by a unit qualifier and the quantityPackage 40032-0450-11. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nitrofurantoin Oral Suspension, USP is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with nitrofurantoin oral suspension, USP are predisposed to persistence or reappearance of bacteriuria. Urine specimens for culture and susceptibility …
Excerpt only. Read the full label for complete information.
About NDC 40032-450
- What is NDC 40032-450?
- 40032-450 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/5mL suspension, listed with the FDA by Novel Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin.
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Novel Laboratories, Inc., NDC labeler code 40032. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrofurantoin?
- 43 other product NDCs are listed under this name. See all Nitrofurantoin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantoin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | SuspensionOral | Camber Pharmaceuticals, Inc. | 31722-491 | 31722-0491-23 |
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | For suspensionOral | Somerset Therapeutics, LLC | 70069-829 | 70069-0829-01 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4244 | 70518-4244-00 |
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | SuspensionOral | Biocon Pharma Inc | 70377-118 | 70377-0118-31 |
| Nitrofurantoin | Nitrofurantoin 100 mg/1 | CapsuleOral | Micro Labs Limited | 42571-393 | 42571-0393-0142571-0393-0542571-0393-90 |
| Nitrofurantoin | Nitrofurantoin 50 mg/5mL | SuspensionOral | Rising Pharma Holdings, Inc. | 16571-888 | 16571-0888-06 |
| nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7217 | 50090-7217-0050090-7217-0250090-7217-03 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-853 | 60760-0853-14 |
| Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3569 | 68071-3569-0168071-3569-0268071-3569-04 |
| Nitrofurantoin | Nitrofurantoin monohydrate 25 mg/5mL | SuspensionOral | Aurobindo Pharma Limited | 59651-206 | 59651-0206-23 |
Other NDCs under ANDA 201693
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 |
|---|---|---|---|---|
| Nitrofurantoin | Nitrofurantoin 25 mg/5mL | SuspensionOral | Lupin Pharmaceuticals,Inc. | 43386-450 |