NDC 0904-6935

Paliperidone

Paliperidone

Paliperidone is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Paliperidone.

Product ID0904-6935_528a962a-4924-4c48-93ce-6ab1f019e52c
NDC0904-6935
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2018-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA205618
Labeler NameMajor Pharmaceuticals
Substance NamePALIPERIDONE
Active Ingredient Strength3 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6935-61

100 BLISTER PACK in 1 CARTON (0904-6935-61) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2018-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6935-61 [00904693561]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-01

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE3 mg/1

Pharmacological Class

  • Atypical Antipsychotic [EPC]
  • Atypical Antipsychotic [EPC]

NDC Crossover Matching brand name "Paliperidone" or generic name "Paliperidone"

NDCBrand NameGeneric Name
0378-3978Paliperidonepaliperidone
0378-3979Paliperidonepaliperidone
0378-3980Paliperidonepaliperidone
0378-3981Paliperidonepaliperidone
0591-3692PaliperidonePaliperidone
0591-3693PaliperidonePaliperidone
0591-3694PaliperidonePaliperidone
0591-3695PaliperidonePaliperidone
0904-6935PaliperidonePaliperidone
0904-6936PaliperidonePaliperidone
0904-6937PaliperidonePaliperidone
10147-0951Paliperidonepaliperidone
10147-0952Paliperidonepaliperidone
10147-0953Paliperidonepaliperidone
68151-5041PaliperidonePaliperidone
70518-0850PaliperidonePaliperidone
10147-0954PaliperidonePaliperidone
16714-867PaliperidonePaliperidone
16714-869PaliperidonePaliperidone
16714-866PaliperidonePaliperidone
16714-868PaliperidonePaliperidone
42292-026PaliperidonePaliperidone
42292-027PaliperidonePaliperidone
47335-767PaliperidonePaliperidone
47335-766PaliperidonePaliperidone
47335-765PaliperidonePaliperidone
47335-744PaliperidonePaliperidone
70518-2034PaliperidonePaliperidone
70518-2197PaliperidonePaliperidone
65162-280PaliperidonePaliperidone
65162-281PaliperidonePaliperidone
65162-282PaliperidonePaliperidone
65162-283PaliperidonePaliperidone
49252-033PALIPERIDONEPALIPERIDONE
49252-035PALIPERIDONEPALIPERIDONE
49252-034PALIPERIDONEPALIPERIDONE
49252-032PALIPERIDONEPALIPERIDONE
60687-459PaliperidonePaliperidone
60687-470PaliperidonePaliperidone
43975-350PALIPERIDONEPALIPERIDONE
43975-352PALIPERIDONEPALIPERIDONE
43975-349PALIPERIDONEPALIPERIDONE
43975-351PALIPERIDONEPALIPERIDONE
42292-055PaliperidonePaliperidone
70518-2509PaliperidonePaliperidone
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