NDC 16729-216-01 - 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: 16729-216-01
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 16 of 116 · 2,303 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier unii: B697894SGQ
SEYTU Body Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	c411e9a6-b2ea-446b-a886-b92c61736e6c	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
SEYTU Facial Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	96fd37fb-c3ff-413f-b2c8-50754f320ecc	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	ebfe03e7-614f-44b1-b1f1-78edc7e274cc	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	86630e82-f249-4866-82dd-3e21feb266c4	2026-02-04	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	61835f25-bfe4-49ac-9dbf-3d6387866e78	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938 rxcui: 312941 unii: UTI8907Y6X
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cipla USA Inc.	cf71d1b9-5ebb-429f-a07f-a87cd168250f	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938 rxcui: 312940 rxcui: 312941 unii: UTI8907Y6X
Sertraline HCl	SERTRALINE HYDROCHLORIDE	Biocon Pharma Inc.	623b9672-b41e-4ec9-b2cc-f5bb383c39ba	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: UTI8907Y6X
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Zydus Lifesciences Limited	96dedceb-81ad-447c-800e-800cf473d4e4	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: UTI8907Y6X
SHISEIDO SPORTS BB DARK	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	f4fc4b6a-9507-496e-9ecb-8400055ecf2d	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Hampton Sun SPF 30 Mineral	ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	b8ee428e-07d3-4c6c-853c-cfbe3e4002d9	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Cabo	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABO	LE COSMETICS INC	49643a56-3627-67f8-e063-6294a90a2d7b	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Caymans	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANS	LE COSMETICS INC	49644002-153e-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
SURFERS BARRIER SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Avasol LLC	ec55eef0-17e6-416d-bd5e-548f2f323cea	2026-01-26	Warnings	Exact identifier unii: 15FIX9V2JP
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 312938 rxcui: 312940 rxcui: 312941 unii: UTI8907Y6X

Reported adverse events (FAERS/openFDA)#

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