Prescription drug · ANDA

Lurasidone Hydrochloride NDC 53746-880

Lurasidone hydrochloride 40 mg/1 · Tablet, Coated · Oral · Amneal Pharmaceuticals of New York LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)53746-880Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53746-0880Add 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
53746-880-305374608803030 TABLET, COATED in 1 BOTTLE (53746-880-30)Marketed from Jul 5, 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)
Lurasidone Hydrochloride
Generic name (nonproprietary)
lurasidone hydrochloride
Active ingredients
Lurasidone hydrochloride — 40 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Amneal Pharmaceuticals of New York LLCNDC labeler code 53746
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208002
Marketing start
Listing expires
Identifiers
Product ID 53746-880_f81d4ba1-6578-46ad-bbc6-7c80a6e37625SPL ID f81d4ba1-6578-46ad-bbc6-7c80a6e37625SPL set ID 84648adf-b3c6-476e-8d11-2a9d7c5eb550RxCUI 1040031, 1040041, 1235247, 1297278, 1431235UNII O0P4I5851I
Pharmacologic class
Atypical Antipsychotic

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

N453746088030 followed by a unit qualifier and the quantity

Package 53746-0880-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Lurasidone hydrochloride tablets are indicated for: Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2) ] . Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2) ] . Lurasidone hydrochloride is an atypical antipsychotic indicated for the treatment of: Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy. (1, 14.2 ) Depressive episode associated with B…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53746-880

What is NDC 53746-880?
53746-880 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 40 mg/1 tablet, coated, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Lurasidone Hydrochloride.
What is the active ingredient?
Lurasidone hydrochloride.
Who is the labeler?
Amneal Pharmaceuticals of New York LLC, NDC labeler code 53746. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lurasidone Hydrochloride?
131 other product NDCs are listed under this name. See all Lurasidone Hydrochloride 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 Lurasidone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralTorrent Pharmaceuticals Limited13668-73713668-0737-3013668-0737-90
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralCoupler LLC67046-165967046-1659-03
Lurasidone HydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-456370518-4563-00
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1TabletOralCoupler LLC67046-165467046-1654-03
Lurasidone HydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralCoupler LLC67046-163767046-1637-03
Lurasidone HydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-449170518-4491-00
lurasidone hydrochlorideLurasidone hydrochloride 40 mg/1TabletOralREMEDYREPACK INC.70518-442770518-4427-00
lurasidone hydrochlorideLurasidone hydrochloride 80 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62472603-0624-01
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62172603-0621-01
lurasidone hydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62272603-0622-01

All 132 Lurasidone Hydrochloride NDCs

Other NDCs under ANDA 208002

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

FDA NDC Directory listings under ANDA 208002
ProductStrengthForm · routeLabelerProduct NDC
Lurasidone HydrochlorideLurasidone hydrochloride 20 mg/1Tablet, CoatedOralAmneal Pharmaceuticals of New York LLC53746-879
Lurasidone HydrochlorideLurasidone hydrochloride 80 mg/1Tablet, CoatedOralAmneal Pharmaceuticals of New York LLC53746-881
Lurasidone HydrochlorideLurasidone hydrochloride 120 mg/1Tablet, CoatedOralAmneal Pharmaceuticals of New York LLC53746-882
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1Tablet, CoatedOralAmneal Pharmaceuticals of New York LLC53746-082
Lurasidone HydrochlorideLurasidone hydrochloride 20 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-879
Lurasidone HydrochlorideLurasidone hydrochloride 40 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-880
Lurasidone HydrochlorideLurasidone hydrochloride 80 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-881
Lurasidone HydrochlorideLurasidone hydrochloride 120 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-882
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1Tablet, CoatedOralAmneal Pharmaceuticals LLC65162-082

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Lurasidone Hydrochloride NDC 53746-880 | Med-Code