NDC codes

FDA NDC Directory
Product NDC (as listed)69067-010Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69067-0010Add 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
69067-010-15690670010156906700101515 POUCH in 1 CARTON (69067-010-15) / 10 g in 1 POUCHMarketed from Sep 21, 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)
Lactulose
Generic name (nonproprietary)
lactulose
Active ingredients
Lactulose — 10 g/10g
Dosage form
Solution
Route
Oral
Labeler
Foxland Pharmaceuticals, Inc.NDC labeler code 69067
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074712
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 69067-010_4618824a-2b40-3d54-e063-6394a90a4b96SPL ID 4618824a-2b40-3d54-e063-6394a90a4b96SPL set ID 3363bdbd-f0d1-45b3-8193-7fdb0a310cc2RxCUI 1251190, 1251194UNII 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

N469067001015 followed by a unit qualifier and the quantity

Package 69067-0010-15. 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 LACTULOSE For Oral Solution is indicated for the treatment of constipation. In patients with a history of chronic constipation, lactulose 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 69067-010

What is NDC 69067-010?
69067-010 is the product NDC for Lactulose, Lactulose 10 g/10g solution, listed with the FDA by Foxland Pharmaceuticals, Inc.. It has 1 package NDC, 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?
Foxland Pharmaceuticals, Inc., NDC labeler code 69067. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LactuloseLactulose 10 g/15mLSolutionOralAmerican Health Packaging60687-91760687-0917-1460687-0917-6460687-0917-76
LactuloseLactulose 10 g/10gPowder, For solutionOralTrifluent Pharma, Inc.73352-90073352-0900-15
LactuloseLactulose 20 g/20gPowder, For solutionOralTrifluent Pharma, Inc.73352-90573352-0905-15
LactuloseLactulose 10 g/15mLSolutionOralSun Pharmaceutical Industries, Inc.51672-424351672-4243-09
LactuloseLactulose 10 g/10gPowder, For solutionOralPAI Holdings, LLC dba PAI Pharma0121-096500121-0965-30
LactuloseLactulose 20 g/20gPowder, For solutionOralPAI Holdings, LLC dba PAI Pharma0121-193000121-1930-30
LactuloseLactulose 20 g/20gSolutionOralFoxland Pharmaceuticals, Inc.69067-02069067-0020-15
LactuloseLactulose 10 g/15mLSolutionOral, RectalAPOZEAL PHARMACEUTICALS INC83745-24983745-0249-0883745-0249-1683745-0249-32
LactuloseLactulose 10 g/15mLSolutionOralAPOZEAL PHARMACEUTICALS INC83745-40583745-0405-1683745-0405-32
LactuloseLactulose 10 g/15mLSolutionOralXttrium Laboratories, Inc.0116-400500116-4005-0800116-4005-1000116-4005-11+4 more

All 25 Lactulose NDCs

Other NDCs under ANDA 074712

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

FDA NDC Directory listings under ANDA 074712
ProductStrengthForm · routeLabelerProduct NDC
KristaloselactuloseLactulose 10 g/10gPowder, For solutionOralCumberland Pharmaceuticals Inc.66220-719
KristaloselactuloseLactulose 20 g/20gPowder, For solutionOralCumberland Pharmaceuticals Inc.66220-729
LactuloseLactulose 20 g/20gSolutionOralFoxland Pharmaceuticals, Inc.69067-020
LACTULOSE CrystallinelactuloseLactulose 10 g/10gPowder, For solutionOralCumberland Assured Products Inc.85592-819
LACTULOSE CrystallinelactuloseLactulose 20 g/20gPowder, For solutionOralCumberland Assured Products Inc.85592-829

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