Prescription drug · ANDA

Lactulose NDC 0121-1746

Lactulose 20 g/30mL · Solution · Oral · PAI Holdings, LLC dba PAI Pharma

NDC codes

FDA NDC Directory
Product NDC (as listed)0121-1746Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-1746Add 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
0121-1746-00001211746000012117460010 TRAY in 1 CASE (0121-1746-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)Marketed from Dec 3, 2019
0121-1746-0600121174606001211746066 CARTON in 1 CASE (0121-1746-06) / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)Marketed from Dec 3, 2019
0121-1746-4000121174640001211746404 TRAY in 1 CASE (0121-1746-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)Marketed from Dec 3, 2019

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 — 20 g/30mL
Dosage form
Solution
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074623
Marketing start
Listing expires
Other FDA classes
Acidifying Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4SPL ID b73c2ddc-a690-46e1-aa89-40fa890c9ab4SPL set ID cbf0497c-9c8d-4dfa-bebd-64c589468401RxCUI 391937UNII 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

N400121174600 followed by a unit qualifier and the quantity

Package 00121-1746-00. 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 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 0121-1746

What is NDC 0121-1746?
0121-1746 is the product NDC for Lactulose, Lactulose 20 g/30mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. 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?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 074623

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

FDA NDC Directory listings under ANDA 074623
ProductStrengthForm · routeLabelerProduct NDC
LactuloseLactulose 10 g/15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-0873
LactuloseLactulose 20 g/30mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-1154
LactuloseLactulose 10 g/15mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-4577
LactuloseLactulose 10 g/15mLSolutionOralAtlantic Biologicals Corp.17856-0874
LactuloseLactulose 20 g/30mLSolutionOralCardinal Health 107, LLC55154-9448
LactuloseLactulose 10 g/15mLSolutionOralProficient Rx LP82804-107

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