NDC 0378-2004-05 - Paroxetine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0378-2004
Requested NDC: 0378-2004-05
Package NDCs from labels: 0378-2004-93, 0378-2004-05
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2021-10-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Paroxetine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL
Paroxetine Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-05-17	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2004-05	EA - Each	0378-2004	9cb25266-746c-4c3b-903c-204a346caeb3	1	2012-07-24
0378-2004-93	EA - Each	0378-2004	d8a37f7f-5f2a-46c5-85c8-1be169fc0280	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7a2bd17d-0ea7-4326-9939-a747869c01d2	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a396c0eb-f91f-4732-9c20-6b25aa0634b7	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	18b21fba-f6ee-4ac5-a536-096716f51da0	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	13c34bba-f939-4aa7-9457-9d6025902e06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d12905b6-97aa-429a-8800-23856fe31f06	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	43599d17-81f4-4c6e-b6bd-d1e700b668ee	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	116f09db-f859-40c5-8857-33503903ee76	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	480e5bf9-8e24-4335-a434-93255ceb640e	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7057feab-20fe-4547-8223-0816904bcfd6	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	672a804d-ba8e-4c03-91fc-3edc0b12c627	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b656394d-a410-4f8c-a632-815a349fb17e	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4d47292f-35f2-4e9f-a9d8-2df57cbe92cf	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	96258152-5255-4f04-9a35-c5a76b9c0520	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5df158da-3280-4ce6-a04c-370999343400	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	be60feb0-8c16-4ef6-a36f-423ed18e098c	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d7678b4-b082-4911-80a2-c019eb529414	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	00c9da7c-d4c7-49da-afa9-1fde93a81540	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	201acd8e-23c6-43fd-81dc-a814c3d8160b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b24806b1-d9da-4373-b072-6d9a262ea365	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c981ae5e-e7e8-484b-b682-fb96d501e03b	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.