What is NDC 83745-249?

83745-249 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. It has 3 package NDCs, shown above in 10- and 11-digit form.

APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. 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 83745-249 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83745-249Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83745-0249Add 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
83745-249-08	8374502490883745024908	237 mL in 1 BOTTLE (83745-249-08)Marketed from Dec 20, 2024
83745-249-16	8374502491683745024916	473 mL in 1 BOTTLE (83745-249-16)Marketed from Dec 20, 2024
83745-249-32	8374502493283745024932	946 mL in 1 BOTTLE (83745-249-32)Marketed from Dec 20, 2024

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): Lactulose
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral, Rectal
Labeler: APOZEAL PHARMACEUTICALS INCNDC labeler code 83745
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203762
Marketing start: Dec 20, 2024
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 83745-249_2341cf95-5e57-47ab-9dc3-73afa86b786dSPL ID 2341cf95-5e57-47ab-9dc3-73afa86b786dSPL set ID a8af7389-3699-4873-b05a-509af7e8eaabRxCUI 391937UNII 9U7D5QH5AEUPC 0383745249324, 0383745249089, 0383745249164
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N483745024908 followed by a unit qualifier and the quantity

Package 83745-0249-08. 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 Jan 6, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by the improvement in the patients’ mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients’ protein tolerance is also frequently observed with lactulose therapy. In the treatment of chronic portal-systemic encephalopathy, lactulose has been given for over 2 y…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83745-249

What is NDC 83745-249?: 83745-249 is the product NDC for Lactulose, Lactulose 10 g/15mL solution, listed with the FDA by APOZEAL PHARMACEUTICALS INC. It has 3 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?: APOZEAL PHARMACEUTICALS INC, NDC labeler code 83745. 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	APOZEAL PHARMACEUTICALS INC	83745-405	83745-0405-1683745-0405-32
Lactulose	Lactulose 10 g/15mL	SolutionOral	Xttrium Laboratories, Inc.	0116-4005	00116-4005-0800116-4005-1000116-4005-11+4 more
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