Fluphenazine Hydrochloride

Product NDC: 50268-369
11-digit product format: 502680369
Labeler code: 50268
Product ID: 50268-369_2b499b3f-f98a-d07d-e063-6294a90ab453
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluphenazine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvPAK
Application: ANDA214534
Marketing category: ANDA
Marketing start: 2022-04-06
Substance: FLUPHENAZINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUPHENAZINE HYDROCHLORIDE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	ZOU145W1XL
Rxcui	859841

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4255c821-309e-3e59-d8e2-48974bad3552	Product name	8	20250626
817a13b7-685c-6d80-08bc-347c9a7530c4	Product name	4	20240419
817a13b7-685c-6d80-08bc-347c9a7530c4	Product name	3	20171211
adfcae9b-bddd-ca49-dfd9-a2e8267a7d37	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-369-11	Fluphenazine Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
50268-369-15	Fluphenazine Hydrochloride	50 in 1 BOX	TABLET, FILM COATED	50		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-369-11	EA - Each	50268-369	2668e49e-9460-4fc3-bdcb-fb4113292a07	1	2022-05-04
50268-369-15	EA - Each	50268-369	badf9652-7847-4a18-a494-b854a3716d37	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-369	FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20250112_dbfd138a-e107-3f78-e053-2995a90a6d8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859841	fluPHENAZine HCl 10 MG Oral Tablet	PSN	dbfd138a-e107-3f78-e053-2995a90a6d8c	3
859841	fluphenazine hydrochloride 10 MG Oral Tablet	SCD	dbfd138a-e107-3f78-e053-2995a90a6d8c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-369-11	50268036911	1 in 1 BLISTER PACK						Historical
50268-369-15	50268036915	50 BLISTER PACK in 1 BOX (50268-369-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-369-11)	50 blister pack	2022-04-06	0000-00-00	No	No	Current