NDC 16729-216-43 - 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: 16729-216
Requested NDC: 16729-216-43
Package NDCs from labels: 16729-216-10, 16729-216-15, 16729-216-01, 16729-216-16, 16729-216-43
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Effective date: 2026-05-21
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 - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Accord Healthcare, Inc. \| Intas Pharmaceuticals Ltd	Accord Healthcare, Inc. \| Intas Pharmaceuticals Ltd	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - QPharma, Inc. \| Northwind Health Company, LLC	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Quality Care Products, LLC	Quality Care Products, LLC	2024-12-18	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - REMEDYREPACK INC.	REMEDYREPACK INC.	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-08-18	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-08-18	HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride - Direct Rx	Direct Rx	2023-01-12	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - St. Mary's Medical Park Pharmacy	St. Mary's Medical Park Pharmacy	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - A-S Medication Solutions	A-S Medication Solutions	2022-04-13	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2021-08-06	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Unit Dose Services	Unit Dose Services	2021-05-20	HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride Tablets USP	NuCare Pharmaceuticals, Inc.	2021-02-12	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Denton Pharma, Inc. DBA Northwind Pharmaceuticals	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-25	HUMAN PRESCRIPTION DRUG LABEL
Sertraline Hydrochloride - Direct_Rx	Direct_Rx	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2019-04-26	HUMAN PRESCRIPTION DRUG LABEL
SERTRALINE HYDROCHLORIDE - DIRECT RX	DIRECT RX	2018-03-14	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-216-01	SERTRALINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	19
16729-216-10	SERTRALINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	19
16729-216-15	SERTRALINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	19
16729-216-16	SERTRALINE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET, FILM COATED	500	19
16729-216-43	SERTRALINE HYDROCHLORIDE	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-216	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	17	Current NDC, Legacy NDC, 5 package rows	20240106_205ecf52-8138-44a7-ad9a-b3aa7f4fa11a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-216-15	EA - Each	16729-216	244cfc50-a442-4123-bebc-3fe1dd4c1f78	1	2017-03-06
16729-216-16	EA - Each	16729-216	03832b5b-daa3-4a2f-90be-0c1e4075fed3	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, 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 1 of 117 · 2,335 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2026-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940 unii: UTI8907Y6X
Dr.Harry EYES PROTECTION	POLYETHYLENE GLYCOL 400 1% EYES PROTECTION	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5a9fe033-89d3-da62-e063-6294a90a4503	2026-09-03	Warnings	Exact identifier unii: B697894SGQ
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	455c8416-c878-4283-a42f-4df896870a4e	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940 unii: UTI8907Y6X
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b559c20d-70be-41e7-acfb-262ffc3ea878	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940 unii: UTI8907Y6X
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5921f77f-01a2-40b9-ad77-2258865c997d	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941 unii: UTI8907Y6X
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4da914d0-629e-4766-b57f-6119fa8283cf	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312941 unii: UTI8907Y6X
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	677c90cd-6527-40cb-a564-571796513fcb	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938 unii: UTI8907Y6X
Sertraline hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1afd0016-d0ee-4e25-a1a4-b66f228e2f9c	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940 unii: UTI8907Y6X
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2026-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938 rxcui: 312941 unii: UTI8907Y6X
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Rohto Max Strength	NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80	The Mentholatum Company	e4b49550-1ca3-4bd7-854d-409b53fa5e26	2026-08-20	Warnings	Exact identifier unii: 6OZP39ZG8H
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline	SERTRALINE	Preferred Pharmaceuticals Inc.	957ba196-0b9b-4cda-bd15-28357ced8d2f	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312940 unii: UTI8907Y6X
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
Sertraline HCl	SERTRALINE HYDROCHLORIDE	Umedica Laboratories USA Inc.	a6d0f35c-f4f4-456d-b8d9-d56297261ad6	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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