NDC 55111-249-79 - Quetiapine fumarate

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: 55111-249
Requested NDC: 55111-249-79
Package NDCs from labels: 55111-249-30, 55111-249-60, 55111-249-01, 55111-249-05, 55111-249-79, 55111-249-78
Manufacturer: Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited -FTO III
Effective date: 2019-04-25
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Quetiapine fumarate - Dr.Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited -FTO III	Dr.Reddy's Laboratories Limited \| Dr.Reddy's Laboratories Limited -FTO III	2019-04-25	HUMAN PRESCRIPTION DRUG LABEL
Quetiapine fumarate - Major Pharmaceuticals	Major Pharmaceuticals	2017-07-26	HUMAN PRESCRIPTION DRUG LABEL
Quetiapine fumarate - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2012-04-23	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-249	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	16	Legacy NDC	20190503_26d92d06-44c5-51ac-27f2-cb1376f6bb68.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-249-01	EA - Each	55111-249	18b28221-d220-4579-9ef9-b5859992f6f5	1	2012-07-24
55111-249-05	EA - Each	55111-249	3f192733-3953-4d91-8fa0-730eb96b351b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED ]	10
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	3
QUETIAPINE FUMARATE	ACTIVE INGREDIENT	2S3PL1B6UJ	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
QUETIAPINE	ACTIVE MOIETY	BGL0JSY5SI	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
colloidal silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	QUETIAPINE FUMARATE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

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 4 of 146 · 2,914 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cover Creme	TITANIUM DIOXIDE	Baxter of California	31f5e8c4-523f-4596-e063-6294a90a6a12	2026-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Smogstat	ECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA	Energique, Inc.	59f63e2b-24fa-43a0-8334-02e6729c6ac1	2026-07-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Muscle Ice	PHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)	Peaceful Mountain, Inc.	03b6e2a9-f335-4ae2-9011-80bd019afb72	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	c6c454c4-3eae-48ae-bf17-5dccdb659141	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 616487 unii: 2S3PL1B6UJ
Bioplasma	SILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDE	Hyland's Inc.	dd0a7ed2-d112-4b96-e053-2995a90ac6b6	2026-07-30	Warnings	Exact identifier unii: ETJ7Z6XBU4
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	d38f0f4e-dc0f-4c92-a212-c4da3db74801	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 2S3PL1B6UJ
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S.A.	575fb2c3-e332-8a3b-e063-6394a90a9fd9	2026-07-24	Warnings	Exact identifier unii: 15FIX9V2JP
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS	POLYVINYL ALCOHOL, POVIDONE	AmerisourceBergen	ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f	2026-07-22	Warnings	Exact identifier unii: FZ989GH94E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	3085f68d-e83c-4f59-b058-8bdae7f4e537	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312743 unii: 2S3PL1B6UJ
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b8864cb9-1c6a-4e36-9893-eb1403ee8745	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312744 unii: 2S3PL1B6UJ
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
QUETIAPINE	QUETIAPINE	REMEDYREPACK INC.	90da6c48-3282-41dc-b4fa-75d33efa9fee	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 2S3PL1B6UJ
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	ea9b9ed1-4be0-4dc0-b1dd-239caff5253e	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312743 unii: 2S3PL1B6UJ
Quetiapine	QUETIAPINE	Major Pharmaceuticals	b02324b1-e7f0-4cbc-8778-5f7c4a5d194a	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 2S3PL1B6UJ
Quetiapine fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	02b19885-2987-4c46-8d2a-5e59656f72e8	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 317174 unii: 2S3PL1B6UJ
Prid	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	49689eeb-7790-07f1-e063-6294a90a2df2	2026-07-16	Warnings	Exact identifier unii: ETJ7Z6XBU4
QUETIAPINE	QUETIAPINE	REMEDYREPACK INC.	67872105-4ec6-4d46-b3b4-c672c93576d2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 2S3PL1B6UJ

Reported adverse events (FAERS/openFDA)#

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