What is NDC 54092-476?

54092-476 is the product NDC for Lialda (mesalamine), Mesalamine 1.2 g/1 tablet, delayed release, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lialda?

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.

Lialda NDC 54092-476 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)54092-476Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54092-0476Add 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
54092-476-01	5409204760154092047601	120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)Marketed from Jan 16, 2007
54092-476-02	5409204760254092047602	12 BOTTLE in 1 CARTON (54092-476-02) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)Marketed from Jan 16, 2007
54092-476-08	5409204760854092047608	3 CARTON in 1 CARTON (54092-476-08) / 8 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACKMarketed from Jan 16, 2007
54092-476-12	5409204761254092047612	120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)Marketed from Jan 16, 2007

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): Lialda
Generic name (nonproprietary): mesalamine
Active ingredients: Mesalamine — 1.2 g/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.NDC labeler code 54092
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022000
Marketing start: Jan 16, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Aminosalicylic Acids (Chemical structure)
Identifiers: Product ID 54092-476_405a190f-df13-4578-a988-5b291b284f21SPL ID 405a190f-df13-4578-a988-5b291b284f21SPL set ID 3098a080-be86-4265-9818-7fc4beab77b7RxCUI 686429, 686433UNII 4Q81I59GXC
Pharmacologic class: Aminosalicylate

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

N454092047601 followed by a unit qualifier and the quantity

Package 54092-0476-01. 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 Oct 26, 2026.

Indications (excerpt from the label)

LIALDA ® is indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. LIALDA is an aminosalicylate indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 ) treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54092-476

What is NDC 54092-476?: 54092-476 is the product NDC for Lialda (mesalamine), Mesalamine 1.2 g/1 tablet, delayed release, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lialda (Mesalamine).
What is the active ingredient?: Mesalamine.
Who is the labeler?: Takeda Pharmaceuticals America, Inc., NDC labeler code 54092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lialda?: 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 NDA 022000

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

FDA NDC Directory listings under NDA 022000
Product	Strength	Form · route	Labeler	Product NDC
Mesalamine	Mesalamine 1.2 g/1	Tablet, Delayed releaseOral	Takeda Pharmaceuticals America, Inc.	54092-100

Lialda (Mesalamine) NDC 54092-476