Prescription drug · ANDA
nitrofurantoin macrocrystals NDC 72603-184
Nitrofurantoin 100 mg/1 · Capsule · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72603-184-01 | 72603018401 | 100 CAPSULE in 1 BOTTLE (72603-184-01)Marketed from Dec 1, 2023 |
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 macrocrystals
- Generic name (nonproprietary)
- nitrofurantoin macrocrystals
- Active ingredients
- Nitrofurantoin — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217272
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 72603-184_3dfb2c77-98f5-4810-a491-b0b0198bd9c1SPL ID 3dfb2c77-98f5-4810-a491-b0b0198bd9c1SPL set ID 1e3c284a-539d-4923-a5f6-547390baf811RxCUI 311994, 311995, 1648759UNII 927AH8112LUPC 0372603183016, 0372603182019, 0372603184013
- 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
N472603018401followed by a unit qualifier and the quantityPackage 72603-0184-01. 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 (macrocrystals) are 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 (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susce…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217272
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 macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-131 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | American Health Packaging | 60687-839 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-850 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-015 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3827 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | VERITYRX, LLC | 83939-0016 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-340 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-410 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-411 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-412 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-605 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-603 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-604 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2212 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Redpharm Drug | 67296-2251 |
| nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7217 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Direct_Rx | 61919-842 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2254 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-182 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-183 |