Paliperidone

Product NDC: 60687-459
11-digit product format: 606870459
Labeler code: 60687
Product ID: 60687-459_40d407c3-846c-cbe7-e063-6294a90a2a81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paliperidone
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA205618
Marketing category: ANDA
Marketing start: 2020-01-15
Substance: PALIPERIDONE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Paliperidone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALIPERIDONE	3 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	838F01T721
Rxcui	672567, 672569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3752075e-d817-45ea-9aa1-8dc0301cf2aa	Product name	1	20251114
893dce58-6330-4a9a-ab03-5ffd7148e184	Product name	1	20250311
b6847380-b533-d626-e29e-10b60b2ad451	Product name	9	20250303
fd328049-536a-4914-b42e-93bf4d93db24	Product name	1	20220307
0f0756fc-4d63-4f75-afcc-9c5e62a38d69	Product name	2	20220304

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60687-459-01	Paliperidone	100 in 1 BOX, UNIT-DOSE	TABLET, EXTENDED RELEASE	100		4
60687-459-11	Paliperidone	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-459-01	EA - Each	60687-459	25b78798-dede-40c1-8926-c13bfbcb9e7f	1	2019-12-10
60687-459-11	EA - Each	60687-459	3993e19d-bfb2-4b0b-b8f3-0b667ce24418	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-459	PALIPERIDONE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3	Current NDC, Legacy NDC, 2 package rows	20240509_c6d80cc0-596e-49b9-8216-34e7b01e2df2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
672567	paliperidone 3 MG 24HR Extended Release Oral Tablet	PSN	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4
672569	paliperidone 6 MG 24HR Extended Release Oral Tablet	PSN	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4
672567	24 HR paliperidone 3 MG Extended Release Oral Tablet	SCD	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4
672569	24 HR paliperidone 6 MG Extended Release Oral Tablet	SCD	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4
672567	paliperidone 3 MG 24 HR Extended Release Oral Tablet	SY	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4
672569	paliperidone 6 MG 24 HR Extended Release Oral Tablet	SY	c6d80cc0-596e-49b9-8216-34e7b01e2df2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-459-01	60687045901	100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-459-01) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-459-11)	100 blister pack	2020-01-15	0000-00-00	No	No	Current
60687-459-11	60687045911	1 in 1 BLISTER PACK						Historical