NDC 60687-470

Paliperidone

Paliperidone

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

Product ID60687-470_9715cdc9-078e-7c21-e053-2995a90a2da5
NDC60687-470
Product TypeHuman Prescription Drug
Proprietary NamePaliperidone
Generic NamePaliperidone
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-11-11
Marketing CategoryANDA / ANDA
Application NumberANDA205618
Labeler NameAmerican Health Packaging
Substance NamePALIPERIDONE
Active Ingredient Strength6 mg/1
Pharm ClassesAtypical Antipsychotic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60687-470-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-470-01) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-470-11)
Marketing Start Date2019-11-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-470-01 [60687047001]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-11

NDC 60687-470-11 [60687047011]

Paliperidone TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205618
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-11

Drug Details

Active Ingredients

IngredientStrength
PALIPERIDONE6 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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.