Prescription drug · ANDA
Nitrofurantion NDC 71205-171
Nitrofurantoin 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-171-10 | 7120501711071205017110 | 10 CAPSULE in 1 BOTTLE (71205-171-10)Marketed from Dec 1, 2018 | |
| 71205-171-14 | 7120501711471205017114 | 14 CAPSULE in 1 BOTTLE (71205-171-14)Marketed from Dec 1, 2018 | |
| 71205-171-20 | 7120501712071205017120 | 20 CAPSULE in 1 BOTTLE (71205-171-20)Marketed from Dec 1, 2018 | |
| 71205-171-28 | 7120501712871205017128 | 28 CAPSULE in 1 BOTTLE (71205-171-28)Marketed from Jul 7, 2021 |
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)
- Nitrofurantion
- Generic name (nonproprietary)
- nitrofurantion
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201722
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 71205-171_a1447d12-32dc-4e06-960e-d4c2f2880faeSPL ID a1447d12-32dc-4e06-960e-d4c2f2880faeSPL set ID 870f64ca-0256-4e3f-8c34-dc603ccc41c0RxCUI 1648759UNII 927AH8112LUPC 0371205171148
- 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
N471205017110followed by a unit qualifier and the quantityPackage 71205-0171-10. 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 Capsules, USP (macrocrystals) 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Capsules, USP (macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be ca…
Excerpt only. Read the full label for complete information.
About NDC 71205-171
- What is NDC 71205-171?
- 71205-171 is the product NDC for Nitrofurantion, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantion.
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrofurantion?
- 9 other product NDCs are listed under this name. See all Nitrofurantion NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantion products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nitrofurantion | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Labortories | 68001-384 | 68001-0384-00 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Labortories | 68001-385 | 68001-0385-00 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Labortories | 68001-386 | 68001-0386-00 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5693 | 50090-5693-0050090-5693-0250090-5693-03 |
| Nitrofurantion | Nitrofurantoin 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-231 | 57664-0231-1857664-0231-88 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-232 | 57664-0232-1857664-0232-88 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-233 | 57664-0233-1857664-0233-88 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2363 | 68071-2363-0768071-2363-08 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0024 | 71335-0024-0171335-0024-0271335-0024-03+6 more |
Other NDCs under ANDA 201722
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 |
|---|---|---|---|---|
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5693 |
| Nitrofurantion | Nitrofurantoin 25 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-231 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-232 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Sun Pharmaceutical Industries, Inc. | 57664-233 |
| Nitrofurantion | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Labortories | 68001-384 |
| Nitrofurantion | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Labortories | 68001-385 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Labortories | 68001-386 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2363 |
| Nitrofurantion | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-0024 |