What is NDC 13811-719?

13811-719 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Trigen Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Nitrofurantoin, Nitrofurantoin monohydrate.

Trigen Laboratories, LLC, NDC labeler code 13811. 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 13811-719 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)13811-719Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13811-0719Add 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
13811-719-10	1381107191013811071910	100 CAPSULE in 1 BOTTLE (13811-719-10)Marketed from Jan 1, 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
Generic name (nonproprietary): nitrofurantoin
Active ingredients: Nitrofurantoin — 25 mg/1Nitrofurantoin monohydrate — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Trigen Laboratories, LLCNDC labeler code 13811
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208516
Marketing start: Jan 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Nitrofurans (Chemical structure)Nitrofurans (Chemical structure)
Identifiers: Product ID 13811-719_fb696b06-d8b4-81df-e053-6394a90af1e3SPL ID fb696b06-d8b4-81df-e053-6394a90af1e3SPL set ID 39ffb8c6-4dd8-4436-b857-7306c15f662aRxCUI 1648755UNII 927AH8112L, E1QI2CQQ1IUPC 0313811719109
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

N413811071910 followed by a unit qualifier and the quantity

Package 13811-0719-10. 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 May 11, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of Escherichia coli or Staphylococcus saprophyticus . 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 (monohydrate/macrocrystals) and other antibacterial drugs, Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13811-719

What is NDC 13811-719?: 13811-719 is the product NDC for Nitrofurantoin, Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1 capsule, listed with the FDA by Trigen Laboratories, 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, Nitrofurantoin monohydrate.
Who is the labeler?: Trigen Laboratories, LLC, NDC labeler code 13811. 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 208516

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

FDA NDC Directory listings under ANDA 208516
Product	Strength	Form · route	Labeler	Product NDC
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	St. Mary's Medical Park Pharmacy	60760-853
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-2464
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Redpharm Drug, Inc.	67296-1442
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-2928
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Preferred Pharmaceuticals Inc.	68788-8258
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-3717
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Proficient Rx LP	71205-852
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2255
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2320
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2914
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1262
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-386
Nitrofurantoin	Nitrofurantoin 25 mg/1; Nitrofurantoin monohydrate 75 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-387
Nitrofurantoin Monohydrate/Macrocrystal	Nitrofurantoin monohydrate 75 mg/1; Nitrofurantoin 25 mg/1	CapsuleOral	Direct_Rx	72189-395