NDC 70518-2197

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 ID: 70518-2197_8d501073-251c-5139-e053-2995a90a330b
• NDC: 70518-2197
• Product Type: Human Prescription Drug
• Proprietary Name: Paliperidone
• Generic Name: Paliperidone
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-07-09
• Marketing Category: NDA / NDA
• Application Number: NDA021999
• Labeler Name: REMEDYREPACK INC.
• Substance Name: PALIPERIDONE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Atypical Antipsychotic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-2197-0

30 POUCH in 1 BOX (70518-2197-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-2197-1)

• Marketing Start Date: 2019-07-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-2197-0 [70518219700]

Paliperidone TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021999
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-09

NDC 70518-2197-1 [70518219701]

Paliperidone TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021999
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-09

Drug Details

Active Ingredients

Ingredient	Strength
PALIPERIDONE	3 mg/1

OpenFDA Data

• SPL SET ID: ee5ce868-4e3f-41d6-8a5e-2c5a319f22b6
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 838F01T721

Pharmacological Class

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

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

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