What is NDC 63187-245?

63187-245 is the product NDC for Nitrofurantion Macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitrofurantion Macrocrystals NDC 63187-245

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0245Add 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 NDC	11-digit (billing)	Package
63187-245-10	6318702451063187024510	10 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-10)Marketed from Sep 1, 2014
63187-245-14	6318702451463187024514	14 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-14)Marketed from Sep 1, 2016
63187-245-20	6318702452063187024520	20 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-20)Marketed from Sep 1, 2014
63187-245-28	6318702452863187024528	28 CAPSULE in 1 BOTTLE, PLASTIC (63187-245-28)Marketed from Dec 8, 2021

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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016620
Marketing start: Sep 27, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 63187-245_63156793-74b0-444c-bb12-dbe7be60ec91SPL ID 63156793-74b0-444c-bb12-dbe7be60ec91SPL set ID 3b53f9bf-866a-4cb1-9180-7b13896e26baRxCUI 1648759UNII 927AH8112LUPC 0363187245207
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

N463187024510 followed by a unit qualifier and the quantity

Package 63187-0245-10. 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 Nov 1, 2023.

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 63187-245

What is NDC 63187-245?: 63187-245 is the product NDC for Nitrofurantion Macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 4 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 63187. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nitrofurantion Macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-023	71205-0023-1071205-0023-1471205-0023-20+3 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
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantion Macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Proficient Rx LP	71205-023
nitrofurantoin macrocrystals	Nitrofurantoin 100 mg/1	CapsuleOral	Northwind Health Company, LLC	51655-948