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 2 of 145 · 2,885 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Psorinum Complex	PHOSPHORUS, SILICEA, SULPHUR, ALOE	BioActive Nutritional, Inc.	d4746927-e6d4-463d-a084-56ffc48d1e67	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Boneforce HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE	BioActive Nutritional, Inc.	d96ca52b-781d-431c-ad2a-a54fd57eb106	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto Preservative Free Dry Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	f4b1974c-2412-45f6-b79d-88b8a0bcb608	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
Rohto Dry-Aid	POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	8ea5c6c9-48f4-406a-a2cb-9280c546d87d	2026-08-18	Warnings	Exact identifier unii: 6DC9Q167V3
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cerebellum Thalamus A Aurm	CEREBELLUM THALAMUS A AURUM	Uriel Pharmacy Inc.	e1c395b8-9221-401f-8980-c91ff8843458	2026-08-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	CORBY, JR., TERRY L.	594443fd-8e27-4ec6-e063-6294a90a3ff0	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Leader Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	CARDINAL HEALTH 110, LLC. DBA LEADER	2ded4bda-b3c3-4521-8701-5c8446fd148b	2026-08-17	Warnings	Exact identifier unii: B697894SGQ unii: 3NXW29V3WO
BM BM134 DROPS	ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA	BM Private Limited	59023500-89be-cc76-e063-6294a90a6e02	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM173 DROPS	ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN	BM Private Limited	59036ca4-e7bb-bbe7-e063-6394a90a410a	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Paroxetine	PAROXETINE	Preferred Pharmaceuticals Inc.	7d558598-6905-46da-8f34-668456c68411	2026-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
Paroxetine	PAROXETINE	Preferred Pharmaceuticals Inc.	ee38b589-e646-4203-bea5-cc3744fe17c3	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
Paroxetine	PAROXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	605c1d23-c97c-4ea4-92d0-fed351de9d2e	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
Paroxetine	PAROXETINE	REMEDYREPACK INC.	05ec70fd-4c65-495f-ba12-e8433a10b655	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
Adaptopath	ADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUM	Energetix Corporation	41234598-0cb5-41c2-bfbe-1c15ee9bf502	2026-08-11	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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