Prescription drug · ANDA
Nitrofurantoin Macrocrystals NDC 71205-297
Nitrofurantoin 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-297-10 | 7120502971071205029710 | 10 CAPSULE in 1 BOTTLE (71205-297-10)Marketed from Jul 1, 2019 | |
| 71205-297-14 | 7120502971471205029714 | 14 CAPSULE in 1 BOTTLE (71205-297-14)Marketed from Jul 1, 2019 | |
| 71205-297-20 | 7120502972071205029720 | 20 CAPSULE in 1 BOTTLE (71205-297-20)Marketed from Jul 1, 2019 |
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
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073652
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 71205-297_63647c09-e111-4a17-85e7-9f5f1853fad7SPL ID 63647c09-e111-4a17-85e7-9f5f1853fad7SPL set ID c87f65b9-14f7-4962-bff6-58b0d1af75f8RxCUI 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
N471205029710followed by a unit qualifier and the quantityPackage 71205-0297-10. 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)
INDICATIONS AND USAGE Nitrofurantoin Capsules USP (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 USP (Macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules USP (Macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be cau…
Excerpt only. Read the full label for complete information.
About NDC 71205-297
- What is NDC 71205-297?
- 71205-297 is the product NDC for Nitrofurantoin Macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantoin Macrocrystals.
- What is the active ingredient?
- Nitrofurantoin.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nitrofurantoin Macrocrystals?
- 38 other product NDCs are listed under this name. See all Nitrofurantoin Macrocrystals NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantoin Macrocrystals products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| nitrofurantoin (macrocrystals) | Nitrofurantoin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-942 | 59651-0942-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | American Health Packaging | 60687-839 | 60687-0839-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-850 | 60687-0850-01 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Direct_Rx | 61919-842 | 61919-0842-1461919-0842-20 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-182 | 72603-0182-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-183 | 72603-0183-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-184 | 72603-0184-01 |
| nitrofurantoin macrocrystals | Nitrofurantoin 25 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-603 | 68001-0603-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 50 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-604 | 68001-0604-00 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-605 | 68001-0605-00 |
Other NDCs under ANDA 073652
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 |
|---|---|---|---|---|
| Nitrofurantoinnitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1135 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 0115-1645 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | AvPAK | 50268-624 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Redpharm Drug | 67296-2150 |
| Nitrofurantoin Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-270 |