Prescription drug · ANDA

lurasidone hydrochloride NDC 67877-638

Lurasidone hydrochloride 20 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67877-638Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0638Add 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
67877-638-0567877063805500 TABLET, FILM COATED in 1 BOTTLE (67877-638-05)Marketed from Jan 4, 2023
67877-638-306787706383030 TABLET, FILM COATED in 1 BOTTLE (67877-638-30)Marketed from Jan 4, 2023
67877-638-386787706383810 BLISTER PACK in 1 CARTON (67877-638-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-638-33)Marketed from Jan 4, 2023
67877-638-906787706389090 TABLET, FILM COATED in 1 BOTTLE (67877-638-90)Marketed from Jan 4, 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212244
Marketing start
Listing expires
Identifiers
Product ID 67877-638_6e4065a5-2672-4ef4-996d-f9d2f58970d3SPL ID 6e4065a5-2672-4ef4-996d-f9d2f58970d3SPL set ID 36b6bacd-ac11-493b-a8a4-8dad448ed9d5RxCUI 1040031, 1040041, 1235247, 1297278, 1431235UNII O0P4I5851IUPC 0367877639901, 0367877642055, 0367877640303
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

N467877063805 followed by a unit qualifier and the quantity

Package 67877-0638-05. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 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 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 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4260
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 coatedOralAscend Laboratories, LLC67877-639
Lurasidone HydrochlorideLurasidone hydrochloride 20 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-747
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 40 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-758

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lurasidone hydrochloride NDC 67877-638 | Med-Code