Prescription drug · NDA
Nitrofurantion Macrocrystals NDC 71205-023
Nitrofurantoin 50 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-023-10 | 7120500231071205002310 | 10 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-10)Marketed from Apr 2, 2018 | |
| 71205-023-14 | 7120500231471205002314 | 14 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-14)Marketed from Apr 2, 2018 | |
| 71205-023-20 | 7120500232071205002320 | 20 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-20)Marketed from Apr 2, 2018 | |
| 71205-023-30 | 7120500233071205002330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-30)Marketed from Jul 26, 2023 | |
| 71205-023-60 | 7120500236071205002360 | 60 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-60)Marketed from Jul 26, 2023 | |
| 71205-023-90 | 7120500239071205002390 | 90 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-90)Marketed from Jul 26, 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)
- Nitrofurantion Macrocrystals
- Generic name (nonproprietary)
- nitrofurantion macrocrystals
- Active ingredients
- Nitrofurantoin — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016620
- Marketing start
- Listing expires
- Other FDA classes
- Nitrofurans (Chemical structure)
- Identifiers
- Product ID 71205-023_0193ca88-0938-a229-e063-6294a90a4b38SPL ID 0193ca88-0938-a229-e063-6294a90a4b38SPL set ID 29b72c21-ab85-41de-b025-f139e6e13cccRxCUI 311995UNII 927AH8112LUPC 0371205023300
- 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
N471205002310followed by a unit qualifier and the quantityPackage 71205-0023-10. 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 Macrocrystals is 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 and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and s…
Excerpt only. Read the full label for complete information.
About NDC 71205-023
- What is NDC 71205-023?
- 71205-023 is the product NDC for Nitrofurantion Macrocrystals, Nitrofurantoin 50 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nitrofurantion 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 Nitrofurantion Macrocrystals?
- 1 other product NDC are listed under this name. See all Nitrofurantion Macrocrystals NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nitrofurantion 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) |
|---|---|---|---|---|---|
| Nitrofurantion Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-245 | 63187-0245-1063187-0245-1463187-0245-20+1 more |
Other NDCs under NDA 016620
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 |
|---|---|---|---|---|
| Nitrofurantion Macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Proficient Rx LP | 63187-245 |
| nitrofurantoin macrocrystals | Nitrofurantoin 100 mg/1 | CapsuleOral | Northwind Health Company, LLC | 51655-948 |