Prescription drug · ANDA
Nitrofurantoin NDC 71205-852
Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-852-00 | 7120508520071205085200 | 100 CAPSULE in 1 BOTTLE (71205-852-00)Marketed from Nov 23, 2022 | |
| 71205-852-10 | 7120508521071205085210 | 10 CAPSULE in 1 BOTTLE (71205-852-10)Marketed from Nov 23, 2022 | |
| 71205-852-14 | 7120508521471205085214 | 14 CAPSULE in 1 BOTTLE (71205-852-14)Marketed from Nov 23, 2022 | |
| 71205-852-20 | 7120508522071205085220 | 20 CAPSULE in 1 BOTTLE (71205-852-20)Marketed from Nov 23, 2022 | |
| 71205-852-30 | 7120508523071205085230 | 30 CAPSULE in 1 BOTTLE (71205-852-30)Marketed from Nov 23, 2022 | |
| 71205-852-55 | 7120508525571205085255 | 500 CAPSULE in 1 BOTTLE (71205-852-55)Marketed from Nov 23, 2022 |
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/1Nitrofurantoin monohydrate — 75 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 208516
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 71205-852_34d3c103-27b8-454b-9f38-c33157c3b6fcSPL ID 34d3c103-27b8-454b-9f38-c33157c3b6fcSPL set ID 34d3c103-27b8-454b-9f38-c33157c3b6fcRxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0371205852108
- 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
N471205085200followed by a unit qualifier and the quantityPackage 71205-0852-00. 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 (monohydrate/ macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 (monohydrate/ macrocrystals) and other antibacterial drugs,Nitrofurantoin Capsules, USP (monohydrate/ macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by s…
Excerpt only. Read the full label for complete information.
About NDC 71205-852
- What is NDC 71205-852?
- 71205-852 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin.
- What is the active ingredient?
- Nitrofurantoin, Nitrofurantoin monohydrate.
- 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 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 208516
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/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-719 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-853 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2464 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Redpharm Drug, Inc. | 67296-1442 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2928 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8258 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3717 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2255 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2320 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2914 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1262 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-386 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-387 |
| Nitrofurantoin Monohydrate/Macrocrystal | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Direct_Rx | 72189-395 |