Prescription drug · ANDA
Nitrofurantoin NDC 72789-386
Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-386-06 | 72789038606 | 6 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-06)Marketed from Apr 3, 2024 | |
| 72789-386-10 | 72789038610 | 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-10)Marketed from Feb 27, 2024 | |
| 72789-386-14 | 72789038614 | 14 CAPSULE in 1 BOTTLE, PLASTIC (72789-386-14)Marketed from Feb 27, 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/1Nitrofurantoin monohydrate — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- 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 72789-386_40c03d65-8d08-371a-e063-6294a90a7ac6SPL ID 40c03d65-8d08-371a-e063-6294a90a7ac6SPL set ID 37606c6f-0d85-4314-94ae-f7732c7bc8d5RxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0372789386102
- 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
N472789038606followed by a unit qualifier and the quantityPackage 72789-0386-06. 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 sus…
Excerpt only. Read the full label for complete information.
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 Monohydrate/Macrocrystal | Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 | CapsuleOral | Direct_Rx | 72189-395 |
| 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 | Bryant Ranch Prepack | 71335-2914 |
| 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 | PD-Rx Pharmaceuticals, Inc. | 72789-387 |
| 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 | 71335-2255 |
| 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 | Bryant Ranch Prepack | 63629-2464 |
| 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 | Bryant Ranch Prepack | 71335-2320 |
| 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 | REMEDYREPACK INC. | 70518-3717 |
| Nitrofurantoin | Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-852 |