NDC codes

FDA NDC Directory
Product NDC (as listed)72789-270Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72789-0270Add 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
72789-270-0272789027002727890270022 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-02)Marketed from Jan 5, 2023
72789-270-10727890270107278902701010 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-10)Marketed from Sep 1, 2022
72789-270-14727890270147278902701414 CAPSULE in 1 BOTTLE, PLASTIC (72789-270-14)Marketed from Sep 1, 2022

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
PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073652
Marketing start
Listing expires
Other FDA classes
Nitrofurans (Chemical structure)
Identifiers
Product ID 72789-270_56d237ad-8f50-fedc-e063-6394a90a3c69SPL ID 56d237ad-8f50-fedc-e063-6394a90a3c69SPL set ID 536ed022-db80-492d-b6ab-809855ea90fbRxCUI 1648759UNII 927AH8112LUPC 0372789270104
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

N472789027002 followed by a unit qualifier and the quantity

Package 72789-0270-02. 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)

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 72789-270

What is NDC 72789-270?
72789-270 is the product NDC for Nitrofurantoin Macrocrystals, Nitrofurantoin 100 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, 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?
PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
nitrofurantoin (macrocrystals)Nitrofurantoin 25 mg/1CapsuleOralAurobindo Pharma Limited59651-94259651-0942-01
Nitrofurantoin MacrocrystalsNitrofurantoin 50 mg/1CapsuleOralAmerican Health Packaging60687-83960687-0839-01
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralAmerican Health Packaging60687-85060687-0850-01
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralDirect_Rx61919-84261919-0842-1461919-0842-20
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralNorthStar RxLLC72603-18272603-0182-01
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralNorthStar RxLLC72603-18372603-0183-01
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralNorthStar RxLLC72603-18472603-0184-01
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralBluePoint Laboratories68001-60368001-0603-00
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralBluePoint Laboratories68001-60468001-0604-00
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralBluePoint Laboratories68001-60568001-0605-00

All 39 Nitrofurantoin Macrocrystals NDCs

Other NDCs under ANDA 073652

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

FDA NDC Directory listings under ANDA 073652
ProductStrengthForm · routeLabelerProduct NDC
Nitrofurantoinnitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralBryant Ranch Prepack71335-1135
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralAmneal Pharmaceuticals of New York LLC0115-1645
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralAvPAK50268-624
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralRedpharm Drug67296-2150
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP71205-297

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