Prescription drug · ANDA

Lurasidone Hydrochloride NDC 60687-747

Lurasidone hydrochloride 20 mg/1 · Tablet, Film coated · Oral · American Health Packaging

NDC codes

FDA NDC Directory
Product NDC (as listed)60687-747Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0747Add 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
60687-747-21606870747216068707472130 BLISTER PACK in 1 CARTON (60687-747-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-747-11)Marketed from Jun 5, 2023

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 — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
American Health PackagingNDC labeler code 60687
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212244
Marketing start
Listing expires
Identifiers
Product ID 60687-747_2abe376d-e980-af98-e063-6394a90ac3efSPL ID 2abe376d-e980-af98-e063-6394a90ac3efSPL set ID b83e1015-8016-4c7c-8239-8dba3a882e46RxCUI 1040031, 1040041, 1235247, 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

N460687074721 followed by a unit qualifier and the quantity

Package 60687-0747-21. 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 tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 60687-747

What is NDC 60687-747?
60687-747 is the product NDC for Lurasidone Hydrochloride, Lurasidone hydrochloride 20 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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?
129 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 40 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62272603-0622-01
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62172603-0621-01
lurasidone hydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62372603-0623-01

All 130 Lurasidone Hydrochloride NDCs

Other NDCs under ANDA 212244

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

FDA NDC Directory listings under ANDA 212244
ProductStrengthForm · routeLabelerProduct NDC
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7355
lurasidone hydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7356
lurasidone hydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7357
lurasidone hydrochlorideLurasidone hydrochloride 80 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7358
lurasidone hydrochlorideLurasidone hydrochloride 120 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7359
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7170
Lurasidone HydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-758
Lurasidone HydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-769
Lurasidone HydrochlorideLurasidone hydrochloride 80 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-780
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-638
lurasidone hydrochlorideLurasidone hydrochloride 40 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-639
lurasidone hydrochlorideLurasidone hydrochloride 60 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-640
lurasidone hydrochlorideLurasidone hydrochloride 80 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-641
lurasidone hydrochlorideLurasidone hydrochloride 120 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-642
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4260

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