What is NDC 62332-389?

62332-389 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?

43 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitrofurantoin NDC 62332-389 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62332-389Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62332-0389Add 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
62332-389-31	6233203893162332038931	100 CAPSULE in 1 BOTTLE (62332-389-31)Marketed from Jul 1, 2021
62332-389-91	6233203899162332038991	1000 CAPSULE in 1 BOTTLE (62332-389-91)Marketed from Jul 1, 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): Nitrofurantoin
Generic name (nonproprietary): nitrofurantoin
Active ingredients: Nitrofurantoin — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Alembic Pharmaceuticals Inc.NDC labeler code 62332
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211935
Marketing start: Jul 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 62332-389_4b5516b0-5fe8-45f0-a7f9-3bf05081e74fSPL ID 4b5516b0-5fe8-45f0-a7f9-3bf05081e74fSPL set ID a8a0d7d7-1e18-46a7-a1f8-e97499820035RxCUI 311994, 311995, 1648759UNII 927AH8112LUPC 0362332390311, 0362332389315, 0362332391318
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

N462332038931 followed by a unit qualifier and the quantity

Package 62332-0389-31. 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 May 5, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Nitrofurantoin capsules, USP (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 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 c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62332-389

What is NDC 62332-389?: 62332-389 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nitrofurantoin.
What is the active ingredient?: Nitrofurantoin.
Who is the labeler?: Alembic Pharmaceuticals Inc., NDC labeler code 62332. 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?: 43 other product NDCs are listed under this name. See all Nitrofurantoin 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nitrofurantoin	Nitrofurantoin 25 mg/5mL	SuspensionOral	Camber Pharmaceuticals, Inc.	31722-491	31722-0491-23
Nitrofurantoin	Nitrofurantoin 25 mg/5mL	For suspensionOral	Somerset Therapeutics, LLC	70069-829	70069-0829-01
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4244	70518-4244-00
Nitrofurantoin	Nitrofurantoin 25 mg/5mL	SuspensionOral	Biocon Pharma Inc	70377-118	70377-0118-31
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	Micro Labs Limited	42571-393	42571-0393-0142571-0393-0542571-0393-90
Nitrofurantoin	Nitrofurantoin 50 mg/5mL	SuspensionOral	Rising Pharma Holdings, Inc.	16571-888	16571-0888-06
nitrofurantoinnitrofurantoin macrocrystals	Nitrofurantoin 100 mg/1	CapsuleOral	A-S Medication Solutions	50090-7217	50090-7217-0050090-7217-0250090-7217-03
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-853	60760-0853-14
Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals)	Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-3569	68071-3569-0168071-3569-0268071-3569-04
Nitrofurantoin	Nitrofurantoin monohydrate 25 mg/5mL	SuspensionOral	Aurobindo Pharma Limited	59651-206	59651-0206-23

All 44 Nitrofurantoin NDCs

Other NDCs under ANDA 211935

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

FDA NDC Directory listings under ANDA 211935
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin	Nitrofurantoin 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-389
Nitrofurantoin	Nitrofurantoin 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-390
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-391
Nitrofurantoin	Nitrofurantoin 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-390
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-391
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4244
Nitrofurantoin	Nitrofurantoin 100 mg/1	CapsuleOral	Proficient Rx LP	82804-241