NDC codes

FDA NDC Directory
Product NDC (as listed)72603-176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0176Add 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 NDC11-digit (billing)PackageCopy
72603-176-01726030176011 BOTTLE in 1 CARTON (72603-176-01) / 230 mL in 1 BOTTLEMarketed 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
NorthStar Rx LLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216385
Marketing start
Listing expires
Other FDA classes
Nitrofurans (Chemical structure)
Identifiers
Product ID 72603-176_14c9efac-c0b1-7afe-e063-6294a90a39e4SPL ID 14c9efac-c0b1-7afe-e063-6294a90a39e4SPL set ID 04af8b73-7e15-7da8-e063-6294a90af284RxCUI 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

N472603017601 followed by a unit qualifier and the quantity

Package 72603-0176-01. 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 .

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 72603-176

What is NDC 72603-176?
72603-176 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/5mL suspension, listed with the FDA by NorthStar Rx LLC. 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?
NorthStar Rx LLC, NDC labeler code 72603. 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?
44 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NitrofurantoinNitrofurantoin 25 mg/5mLSuspensionOralCamber Pharmaceuticals, Inc.31722-49131722-0491-23
NitrofurantoinNitrofurantoin 25 mg/5mLFor suspensionOralSomerset Therapeutics, LLC70069-82970069-0829-01
NitrofurantoinNitrofurantoin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-424470518-4244-00
NitrofurantoinNitrofurantoin 25 mg/5mLSuspensionOralBiocon Pharma Inc70377-11870377-0118-31
NitrofurantoinNitrofurantoin 100 mg/1CapsuleOralMicro Labs Limited42571-39342571-0393-0142571-0393-0542571-0393-90
NitrofurantoinNitrofurantoin 50 mg/5mLSuspensionOralRising Pharma Holdings, Inc.16571-88816571-0888-06
nitrofurantoinnitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralA-S Medication Solutions50090-721750090-7217-0050090-7217-0250090-7217-03
NitrofurantoinNitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1CapsuleOralSt. Mary's Medical Park Pharmacy60760-85360760-0853-14
Nitrofurantoinnitrofurantoin (monohydrate/macrocrystals)Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-356968071-3569-0168071-3569-0268071-3569-04
NitrofurantoinNitrofurantoin monohydrate 25 mg/5mLSuspensionOralAurobindo Pharma Limited59651-20659651-0206-23

All 45 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
ProductStrengthForm · routeLabelerProduct NDC
NitrofurantoinNitrofurantoin 25 mg/5mLSuspensionOralANI Pharmaceuticals, Inc.70954-496

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