NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4427Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4427Add 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
70518-4427-0705184427007051844270030 TABLET in 1 BLISTER PACK (70518-4427-0)Marketed from Aug 6, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208031
Marketing start
Listing expires
Identifiers
Product ID 70518-4427_5b265037-bc4d-467d-e063-6394a90a32f9SPL ID 5b265037-bc4d-467d-e063-6394a90a32f9
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

N470518442700 followed by a unit qualifier and the quantity

Package 70518-4427-00. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70518-4427

What is NDC 70518-4427?
70518-4427 is the product NDC for lurasidone hydrochloride, Lurasidone hydrochloride 40 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?
REMEDYREPACK INC., NDC labeler code 70518. 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/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
lurasidone hydrochlorideLurasidone hydrochloride 80 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-62472603-0624-01

All 130 lurasidone hydrochloride NDCs

Other NDCs under ANDA 208031

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

FDA NDC Directory listings under ANDA 208031
ProductStrengthForm · routeLabelerProduct NDC
lurasidone hydrochlorideLurasidone hydrochloride 20 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-670
lurasidone hydrochlorideLurasidone hydrochloride 40 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-671
lurasidone hydrochlorideLurasidone hydrochloride 60 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-672
lurasidone hydrochlorideLurasidone hydrochloride 80 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-673
lurasidone hydrochlorideLurasidone hydrochloride 120 mg/1TabletOralLupin Pharmaceuticals, Inc.68180-674

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