Prescription drug · ANDA
nitrofurantoin macrocrystals NDC 68382-559
Nitrofurantoin 50 mg/1 · Capsule · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-559-01 | 68382055901 | 100 CAPSULE in 1 BOTTLE (68382-559-01)Marketed from Feb 15, 2018 | |
| 68382-559-10 | 68382055910 | 1000 CAPSULE in 1 BOTTLE (68382-559-10)Marketed from Feb 15, 2018 | |
| 68382-559-30 | 68382055930 | 10 BLISTER PACK in 1 CARTON (68382-559-30) / 10 CAPSULE in 1 BLISTER PACKMarketed from Feb 15, 2018 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205005
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 68382-559_0d11f48c-867f-471c-a74c-9d50f6a76cfdSPL ID 0d11f48c-867f-471c-a74c-9d50f6a76cfdSPL set ID 2862e49a-66e9-4418-9343-4404036775fcRxCUI 311995, 1648759UNII 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
N468382055901followed by a unit qualifier and the quantityPackage 68382-0559-01. 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 macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptibl…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205005
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 | Zydus Pharmaceuticals (USA) Inc. | 68382-560 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1171 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1170 |
| nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1069 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7026 |