What is NDC 45963-439?

45963-439 is the product NDC for Constulose (lactulose), Lactulose 10 g/15mL solution, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Constulose?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Constulose NDC 45963-439 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45963-439Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45963-0439Add 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
45963-439-63	4596304396345963043963	237 mL in 1 BOTTLE (45963-439-63)Marketed from Feb 28, 2011
45963-439-65	4596304396545963043965	946 mL in 1 BOTTLE (45963-439-65)Marketed from Feb 28, 2011

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): Constulose
Generic name (nonproprietary): lactulose
Active ingredients: Lactulose — 10 g/15mL
Dosage form: Solution
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 45963
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090503
Marketing start: Feb 28, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers: Product ID 45963-439_7fd63ff0-fccd-408a-9c56-2c2fefdb74fcSPL ID 7fd63ff0-fccd-408a-9c56-2c2fefdb74fcSPL set ID 461ec39f-eeb4-4460-9b5c-62367d47162bRxCUI 391937, 544452UNII 9U7D5QH5AE
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

N445963043963 followed by a unit qualifier and the quantity

Package 45963-0439-63. 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 Jun 1, 2022.

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 45963-439

What is NDC 45963-439?: 45963-439 is the product NDC for Constulose (lactulose), Lactulose 10 g/15mL solution, listed with the FDA by Actavis Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Constulose (Lactulose).
What is the active ingredient?: Lactulose.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 45963. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Constulose?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 090503

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

FDA NDC Directory listings under ANDA 090503
Product	Strength	Form · route	Labeler	Product NDC
Lactulose	Lactulose 10 g/15mL	SolutionOral	American Health Packaging	60687-917

Constulose (Lactulose) NDC 45963-439