NDC 54868-5639-4 - SERTRALINE 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: 54868-5639
Requested NDC: 54868-5639-4
Package NDCs from labels: 54868-5639-0, 54868-5639-1, 54868-5639-2, 54868-5639-5, 54868-5639-6, 54868-5639-4
Manufacturer: Physicians Total Care, Inc.
Effective date: 2014-02-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate	Physicians Total Care, Inc.	2014-02-14	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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
54868-5639-0	SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate
54868-5639-1	SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate
54868-5639-2	SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate
54868-5639-5	SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate
54868-5639-6	SERTRALINE HYDROCHLORIDE Tablets and Oral Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54868-5639-0	SERTRALINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
54868-5639-1	SERTRALINE HYDROCHLORIDE	45 in 1 BOTTLE	TABLET, FILM COATED	45	8
54868-5639-2	SERTRALINE HYDROCHLORIDE	10 in 1 BOTTLE	TABLET, FILM COATED	10	8
54868-5639-5	SERTRALINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
54868-5639-6	SERTRALINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-5639	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8	5 package rows	20140214_dfc0d446-cdc0-402b-a094-eae9f1115508.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-5639-0	EA - Each	54868-5639	3fcc2273-fd6a-4240-9fa2-0a06ec335774	1	2012-07-24
54868-5639-1	EA - Each	54868-5639	d776ad75-13d0-41be-8a6a-f89dde88ede0	1	2012-07-24
54868-5639-2	EA - Each	54868-5639	e824729a-0cbe-49f2-9707-b6e3622d58b2	1	2012-07-24
54868-5639-3	EA - Each	54868-5639	ce625c0c-bfcc-4c93-983c-187f15132659	1	2012-07-24
54868-5639-4	EA - Each	54868-5639	689d819e-654a-4609-b0b7-86ad59cefe9b	1	2012-07-24
54868-5639-5	EA - Each	54868-5639	c8e0d8a4-51ce-4d66-b8d2-29eaa464da0b	1	2012-07-24
54868-5639-6	EA - Each	54868-5639	babbb24b-7023-4110-b9b4-f4711453b96c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	8

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 8 of 113 · 2,260 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral Sunscreen	RADICAL RESCUE SPF 30 MINERAL SUNSCREEN	ProTransit, Inc.	38e0139c-bb87-55ba-e063-6294a90a82ee	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
EELHOE Sunscreen	TITANIUM DIOXIDE	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	5196ccb0-4515-7e40-e063-6394a90a09bd	2026-05-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bb65c8d7-318f-4d52-9d74-ca22ce389638	2026-05-07	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	67b90f00-4c82-40cd-af96-f8dedf95f8af	2026-05-06	Warnings	Exact identifier unii: 15FIX9V2JP
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

Reported adverse events (FAERS/openFDA)#

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