What is NDC 0115-1643?

0115-1643 is the product NDC for Nitrofurantoin Macrocrystals, Nitrofurantoin 50 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitrofurantoin Macrocrystals NDC 0115-1643

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1643Add 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	Copy
0115-1643-01	0011516430100115164301	100 CAPSULE in 1 BOTTLE (0115-1643-01)Marketed from Mar 8, 2007
0115-1643-03	0011516430300115164303	1000 CAPSULE in 1 BOTTLE (0115-1643-03)Marketed from Mar 8, 2007

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 073671
Marketing start: Mar 8, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 0115-1643_151534e1-3754-4da0-8fca-8ade53adca20SPL ID 151534e1-3754-4da0-8fca-8ade53adca20SPL set ID 341c75ac-fba5-480d-a221-868c4195cb6fRxCUI 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

N400115164301 followed by a unit qualifier and the quantity

Package 00115-1643-01. 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 Apr 14, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0115-1643

What is NDC 0115-1643?: 0115-1643 is the product NDC for Nitrofurantoin Macrocrystals, Nitrofurantoin 50 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 2 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?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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.

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

Other Nitrofurantoin Macrocrystals NDCs
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

All 39 Nitrofurantoin Macrocrystals NDCs

Other NDCs under ANDA 073671

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 073671
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin Macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	AvPAK	50268-623