What is NDC 0116-4005?

0116-4005 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Xttrium Laboratories, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.

Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lactulose?

24 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Lactulose NDC 0116-4005 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0116-4005Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00116-4005Add 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
0116-4005-08	0011640050800116400508	237 mL in 1 BOTTLE (0116-4005-08)Marketed from Jul 1, 2022
0116-4005-10	0011640051000116400510	100 CASE in 1 CASE (0116-4005-10) / 40 TRAY in 1 CASE (0116-4005-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)Marketed from Jul 1, 2022
0116-4005-11	0011640051100116400511	100 CASE in 1 CASE (0116-4005-11) / 40 TRAY in 1 CASE (0116-4005-41) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)Marketed from Jul 1, 2022
0116-4005-15	0011640051500116400515	15 mL in 1 CUP, UNIT-DOSE (0116-4005-15)Marketed from Jul 1, 2022
0116-4005-16	0011640051600116400516	473 mL in 1 BOTTLE (0116-4005-16)Marketed from Jul 1, 2022
0116-4005-30	0011640053000116400530	30 mL in 1 CUP, UNIT-DOSE (0116-4005-30)Marketed from Jul 1, 2022
0116-4005-32	0011640053200116400532	946 mL in 1 BOTTLE (0116-4005-32)Marketed from Jul 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Lactulose
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral
Labeler: Xttrium Laboratories, Inc.NDC labeler code 0116
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075911
Marketing start: Jul 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 0116-4005_4f6f0368-4b59-a9df-e063-6294a90ae43cSPL ID 4f6f0368-4b59-a9df-e063-6294a90ae43cSPL set ID df62ad54-5aba-4d05-e053-2a95a90aa48dRxCUI 391937UNII 9U7D5QH5AEUPC 0301164005086, 0301164005161, 0301164005321
Pharmacologic class: Osmotic Laxative

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

N400116400508 followed by a unit qualifier and the quantity

Package 00116-4005-08. 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 Apr 14, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0116-4005

What is NDC 0116-4005?: 0116-4005 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by Xttrium Laboratories, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lactulose.
What is the active ingredient?: Lactulose.
Who is the labeler?: Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lactulose?: 24 other product NDCs are listed under this name. See all Lactulose 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 Lactulose NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lactulose	Lactulose 10 g/15mL	SolutionOral	American Health Packaging	60687-917	60687-0917-1460687-0917-6460687-0917-76
Lactulose	Lactulose 10 g/10g	Powder, For solutionOral	Trifluent Pharma, Inc.	73352-900	73352-0900-15
Lactulose	Lactulose 20 g/20g	Powder, For solutionOral	Trifluent Pharma, Inc.	73352-905	73352-0905-15
Lactulose	Lactulose 10 g/15mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	51672-4243	51672-4243-09
Lactulose	Lactulose 10 g/10g	Powder, For solutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0965	00121-0965-30
Lactulose	Lactulose 20 g/20g	Powder, For solutionOral	PAI Holdings, LLC dba PAI Pharma	0121-1930	00121-1930-30
Lactulose	Lactulose 20 g/20g	SolutionOral	Foxland Pharmaceuticals, Inc.	69067-020	69067-0020-15
Lactulose	Lactulose 10 g/15mL	SolutionOral, Rectal	APOZEAL PHARMACEUTICALS INC	83745-249	83745-0249-0883745-0249-1683745-0249-32
Lactulose	Lactulose 10 g/15mL	SolutionOral	APOZEAL PHARMACEUTICALS INC	83745-405	83745-0405-1683745-0405-32
Lactulose	Lactulose 10 g/15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0873	00121-0873-1500121-0873-1600121-0873-32

All 25 Lactulose NDCs