Prescription drug · ANDA
Nitrofurantoin (monohydrate/macrocrystals) NDC 71335-2377
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2377-0 | 71335237700 | 6 CAPSULE in 1 BOTTLE (71335-2377-0)Marketed from May 29, 2024 | |
| 71335-2377-1 | 71335237701 | 20 CAPSULE in 1 BOTTLE (71335-2377-1)Marketed from May 29, 2024 | |
| 71335-2377-2 | 71335237702 | 14 CAPSULE in 1 BOTTLE (71335-2377-2)Marketed from May 29, 2024 | |
| 71335-2377-3 | 71335237703 | 30 CAPSULE in 1 BOTTLE (71335-2377-3)Marketed from May 29, 2024 | |
| 71335-2377-4 | 71335237704 | 28 CAPSULE in 1 BOTTLE (71335-2377-4)Marketed from May 29, 2024 | |
| 71335-2377-5 | 71335237705 | 60 CAPSULE in 1 BOTTLE (71335-2377-5)Marketed from May 29, 2024 | |
| 71335-2377-6 | 71335237706 | 10 CAPSULE in 1 BOTTLE (71335-2377-6)Marketed from May 29, 2024 | |
| 71335-2377-7 | 71335237707 | 90 CAPSULE in 1 BOTTLE (71335-2377-7)Marketed from May 29, 2024 | |
| 71335-2377-8 | 71335237708 | 21 CAPSULE in 1 BOTTLE (71335-2377-8)Marketed from May 29, 2024 | |
| 71335-2377-9 | 71335237709 | 8 CAPSULE in 1 BOTTLE (71335-2377-9)Marketed from May 29, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 (monohydrate/macrocrystals)
- Generic name (nonproprietary)
- nitrofurantoin (monohydrate/macrocrystals)
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217357
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
- Identifiers
- Product ID 71335-2377_140ec378-126e-409d-8cbd-46f9e343a9efSPL ID 140ec378-126e-409d-8cbd-46f9e343a9efSPL set ID 63a4b367-bf4b-4b5f-b3e9-394ba307886dRxCUI 1648755UNII E1QI2CQQ1I, 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
N471335237700followed by a unit qualifier and the quantityPackage 71335-2377-00. 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 (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 (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217357
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 (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1198 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-196 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1271 |
| Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3569 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Proficient Rx LP | 82804-115 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3593 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Redpharm Drug | 67296-2105 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8571 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-404 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-606 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4026 |
| Nitrofurantoin (monohydrate/macrocrystals) | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4358 |