NDC 65162-880

Lurasidone Hydrochloride

Lurasidone Hydrochloride

Lurasidone Hydrochloride is a Oral Tablet, Coated in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Lurasidone Hydrochloride.

Product ID65162-880_77617a58-3361-4b73-84dd-db015229ae46
NDC65162-880
Product TypeHuman Prescription Drug
Proprietary NameLurasidone Hydrochloride
Generic NameLurasidone Hydrochloride
Dosage FormTablet, Coated
Route of AdministrationORAL
Marketing Start Date2023-01-02
Marketing CategoryANDA /
Application NumberANDA208002
Labeler NameAmneal Pharmaceuticals LLC
Substance NameLURASIDONE HYDROCHLORIDE
Active Ingredient Strength40 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 65162-880-03

30 TABLET, COATED in 1 BOTTLE (65162-880-03)
Marketing Start Date2023-01-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-880-09 [65162088009]

Lurasidone Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA208002
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03
Marketing End Date2019-02-18

NDC 65162-880-50 [65162088050]

Lurasidone Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA208002
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03
Marketing End Date2019-02-18

NDC 65162-880-03 [65162088003]

Lurasidone Hydrochloride TABLET, COATED
Marketing CategoryANDA
Application NumberANDA208002
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-03
Marketing End Date2019-02-18

Drug Details

NDC Crossover Matching brand name "Lurasidone Hydrochloride" or generic name "Lurasidone Hydrochloride"

NDCBrand NameGeneric Name
13668-464Lurasidone HydrochlorideLurasidone Hydrochloride
13668-465Lurasidone HydrochlorideLurasidone Hydrochloride
13668-466Lurasidone HydrochlorideLurasidone Hydrochloride
13668-467Lurasidone HydrochlorideLurasidone Hydrochloride
46708-494Lurasidone HydrochlorideLurasidone Hydrochloride
46708-495Lurasidone HydrochlorideLurasidone Hydrochloride
46708-496Lurasidone HydrochlorideLurasidone Hydrochloride
46708-497Lurasidone HydrochlorideLurasidone Hydrochloride
46708-498Lurasidone HydrochlorideLurasidone Hydrochloride
62332-494Lurasidone HydrochlorideLurasidone Hydrochloride
62332-495Lurasidone HydrochlorideLurasidone Hydrochloride
62332-496Lurasidone HydrochlorideLurasidone Hydrochloride
62332-497Lurasidone HydrochlorideLurasidone Hydrochloride
62332-498Lurasidone HydrochlorideLurasidone Hydrochloride
65162-082Lurasidone HydrochlorideLurasidone Hydrochloride
65162-879Lurasidone HydrochlorideLurasidone Hydrochloride
65162-880Lurasidone HydrochlorideLurasidone Hydrochloride
65162-881Lurasidone HydrochlorideLurasidone Hydrochloride
65162-882Lurasidone HydrochlorideLurasidone Hydrochloride
67877-638lurasidone hydrochloridelurasidone hydrochloride
67877-639lurasidone hydrochloridelurasidone hydrochloride
67877-640lurasidone hydrochloridelurasidone hydrochloride
67877-641lurasidone hydrochloridelurasidone hydrochloride
67877-642lurasidone hydrochloridelurasidone hydrochloride
63402-302Latudalurasidone hydrochloride
63402-304Latudalurasidone hydrochloride
63402-306Latudalurasidone hydrochloride
63402-308Latudalurasidone hydrochloride
63402-312Latudalurasidone hydrochloride
70518-1812Latudalurasidone hydrochloride
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