NDC codes

FDA NDC Directory
Product NDC (as listed)71205-023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0023Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71205-023-10712050023107120500231010 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-10)Marketed from Apr 2, 2018
71205-023-14712050023147120500231414 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-14)Marketed from Apr 2, 2018
71205-023-20712050023207120500232020 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-20)Marketed from Apr 2, 2018
71205-023-30712050023307120500233030 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-30)Marketed from Jul 26, 2023
71205-023-60712050023607120500236060 CAPSULE in 1 BOTTLE, PLASTIC (71205-023-60)Marketed from Jul 26, 2023
71205-023-90712050023907120500239090 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

N471205002310 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nitrofurantion Macrocrystals NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nitrofurantion MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP63187-24563187-0245-1063187-0245-1463187-0245-20+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.

FDA NDC Directory listings under NDA 016620
ProductStrengthForm · routeLabelerProduct NDC
Nitrofurantion MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP63187-245
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralNorthwind Health Company, LLC51655-948

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