Prescription drug · ANDA
Nitrofurantoin Monohydrate/Macrocrystal NDC 72189-395
Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-395-10 | 72189039510 | 10 CAPSULE in 1 BOTTLE (72189-395-10)Marketed from Nov 22, 2022 | |
| 72189-395-14 | 72189039514 | 14 CAPSULE in 1 BOTTLE (72189-395-14)Marketed from Nov 22, 2022 | |
| 72189-395-20 | 72189039520 | 20 CAPSULE in 1 BOTTLE (72189-395-20)Marketed from Nov 22, 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 Monohydrate/Macrocrystal
- Generic name (nonproprietary)
- nitrofurantoin monohydrate/macrocrystal
- Active ingredients
- Nitrofurantoin monohydrate — 75 mg/1Nitrofurantoin — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_Rx
- 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 72189-395_1e79886c-8ce2-c6ef-e063-6394a90a7a83SPL ID 1e79886c-8ce2-c6ef-e063-6394a90a7a83SPL set ID ee13cf2a-cde0-8ab8-e053-2a95a90a9ddaRxCUI 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
N472189039510followed by a unit qualifier and the quantityPackage 72189-0395-10. 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)
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 susceptible bacteria. Whe…
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 | 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. | 72789-386 |
| 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 |