Prescription drug · ANDA
Nitrofurantoin NDC 70377-118
Nitrofurantoin 25 mg/5mL · Suspension · Oral · Biocon Pharma Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70377-118-31 | 7037701183170377011831 | 1 BOTTLE, GLASS in 1 CARTON (70377-118-31) / 230 mL in 1 BOTTLE, GLASSMarketed from Nov 15, 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)
- Nitrofurantoin
- Generic name (nonproprietary)
- nitrofurantoin
- Active ingredients
- Nitrofurantoin — 25 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Biocon Pharma IncNDC labeler code 70377
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218346
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 70377-118_3cd77dd5-7b86-a52f-fa61-69afc7b4c6b6SPL ID 3cd77dd5-7b86-a52f-fa61-69afc7b4c6b6SPL set ID 68c718a7-2e8f-288c-37d2-053372ee61b9RxCUI 311989UNII 927AH8112LUPC 0370377118319
- 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
N470377011831followed by a unit qualifier and the quantityPackage 70377-0118-31. 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)
Nitrofurantoin oral suspension is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin oral suspension is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions ( 5.7 )]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin oral suspension and other antibacterial drugs, nitrofurantoin oral suspension should be used only to treat or prevent infections that ar…
Excerpt only. Read the full label for complete information.
About NDC 70377-118
- What is NDC 70377-118?
- 70377-118 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/5mL suspension, listed with the FDA by Biocon Pharma 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?
- Biocon Pharma Inc, NDC labeler code 70377. 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 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 |
| Nitrofurantoin | Nitrofurantoin monohydrate 25 mg/5mL | SuspensionOral | Rising Pharma Holdings, Inc. | 64980-593 | 64980-0593-24 |