Quetiapine Fumarate

Product NDC: 52817-160
11-digit product format: 528170160
Labeler code: 52817
Product ID: 52817-160_b67989d1-c748-3488-e053-2995a90a6a6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TruPharma, LLC
Application: ANDA206260
Marketing category: ANDA
Marketing start: 2017-05-10
Marketing end: 0000-00-00
Substance: QUETIAPINE FUMARATE
Active strength: 50 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52817-160-60	EA - Each	52817-160	34fae51b-ba74-4dd6-80d2-b4f728184c65	1	2017-06-15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
853201	QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet	PSN	245f426a-f1b5-4641-8ada-aae02da3ee59	2
853201	24 HR quetiapine 50 MG Extended Release Oral Tablet	SCD	245f426a-f1b5-4641-8ada-aae02da3ee59	2
853201	quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet	SY	245f426a-f1b5-4641-8ada-aae02da3ee59	2
853201	quetiapine 50 MG 24 HR Extended Release Oral Tablet	SY	245f426a-f1b5-4641-8ada-aae02da3ee59	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52817-160-60	52817016060	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-160-60)	2017-05-10	0000-00-00	No	No	Current