What is NDC 68382-560?

68382-560 is the product NDC for nitrofurantoin macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 68382-560

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-560Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0560Add 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
68382-560-01	6838205600168382056001	100 CAPSULE in 1 BOTTLE (68382-560-01)Marketed from Feb 15, 2018
68382-560-10	6838205601068382056010	1000 CAPSULE in 1 BOTTLE (68382-560-10)Marketed from Feb 15, 2018
68382-560-30	6838205603068382056030	10 BLISTER PACK in 1 CARTON (68382-560-30) / 10 CAPSULE in 1 BLISTER PACKMarketed from Feb 15, 2018

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: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205005
Marketing start: Feb 15, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 68382-560_0d11f48c-867f-471c-a74c-9d50f6a76cfdSPL ID 0d11f48c-867f-471c-a74c-9d50f6a76cfdSPL set ID 2862e49a-66e9-4418-9343-4404036775fcRxCUI 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

N468382056001 followed by a unit qualifier and the quantity

Package 68382-0560-01. 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 Nov 10, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Nitrofurantoin macrocrystals capsules 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 macrocrystals capsules and other antibacterial drugs, nitrofurantoin macrocrystals capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptibl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-560

What is NDC 68382-560?: 68382-560 is the product NDC for nitrofurantoin macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. 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?: Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 205005

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

FDA NDC Directory listings under ANDA 205005
Product	Strength	Form · route	Labeler	Product NDC
nitrofurantoinnitrofurantoin macrocrystals	Nitrofurantoin 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-1069
nitrofurantoin macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7026
nitrofurantoin macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Zydus Pharmaceuticals (USA) Inc.	68382-559
nitrofurantoin macrocrystals	Nitrofurantoin 50 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1170
nitrofurantoin macrocrystals	Nitrofurantoin 100 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1171