What is NDC 70954-496?

70954-496 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/5mL suspension, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 70954-496 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-496Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0496Add 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
70954-496-10	7095404961070954049610	230 mL in 1 BOTTLE (70954-496-10)Marketed from Apr 17, 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): Nitrofurantoin
Generic name (nonproprietary): nitrofurantoin
Active ingredients: Nitrofurantoin — 25 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216385
Marketing start: Apr 17, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Nitrofurans (Chemical structure)
Identifiers: Product ID 70954-496_7e94d701-0d57-4a04-bc74-d07febb8ad7bSPL ID 7e94d701-0d57-4a04-bc74-d07febb8ad7bSPL set ID 3b377aff-2d4b-43ea-84c9-8e72c1421b7bRxCUI 311989UNII 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

N470954049610 followed by a unit qualifier and the quantity

Package 70954-0496-10. 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 Oct 8, 2024.

Indications (excerpt from the label)

Nitrofurantoin is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)]. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin and other antibacterial drugs, nitrofurantoin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-496

What is NDC 70954-496?: 70954-496 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/5mL suspension, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 216385

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

FDA NDC Directory listings under ANDA 216385
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin	Nitrofurantoin 25 mg/5mL	SuspensionOral	NorthStar Rx LLC	72603-176