NDC 70518-2034

Paliperidone

Paliperidone

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

Product ID70518-2034_8750f5b7-6d13-2664-e053-2a95a90a9410
NDC70518-2034
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-04-23
Marketing CategoryNDA / NDA
Application NumberNDA021999
Labeler NameREMEDYREPACK INC.
Substance NamePALIPERIDONE
Active Ingredient Strength6 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2034-0

30 POUCH in 1 BOX (70518-2034-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2034-1)
Marketing Start Date2019-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2034-0 [70518203400]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-23

NDC 70518-2034-1 [70518203401]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021999
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-23

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE6 mg/1

OpenFDA Data

SPL SET ID:96e91444-51f2-429f-b4a3-744da2a0fb5c
Manufacturer
UNII

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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