Sertraline

Product NDC: 0143-9655
11-digit product format: 001439655
Labeler code: 0143
Product ID: 0143-9655_f35de481-61af-428e-abb4-a267238b3959
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sertraline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA077864
Marketing category: ANDA
Marketing start: 2012-11-06
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-9655		D	Discontinued by firm	2026-08-17
excluded package	package	0143-9655	0143-9655-05	D	Discontinued by firm	2026-08-17
excluded package	package	0143-9655	0143-9655-09	D	Discontinued by firm	2026-08-17
excluded package	package	0143-9655	0143-9655-30	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9655-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9655-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-9655-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9655-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9655-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-9655-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9655-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9655-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-9655-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9655-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9655-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-9655-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9655-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9655-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-9655-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9655-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9655-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-9655-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9655-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9655-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-9655-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9655-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9655-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-9655-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9655-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9655-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-9655-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9655-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9655-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-9655-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9655-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9655-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-9655-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9655-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9655-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-9655-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077864-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10
A077864-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10
A077864-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077864-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2009-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077864-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2009-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077864-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2009-08-10	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ac594ea-ad8b-47fd-9b52-bbd98301675e	Product name	1	20220317
255fa467-900b-5557-4215-6823352d1150	Product name	2	20211028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9655-05	EA - Each	0143-9655	8febe425-c75c-437b-a64e-f7275d785239	1	2013-07-02
0143-9655-09	EA - Each	0143-9655	fdbc7a26-4f28-4701-b5c6-c4a696409a41	1	2013-07-02
0143-9655-30	EA - Each	0143-9655	ce497642-7fa5-4cac-8b7b-7eea1959090a	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS]	3
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312941	sertraline HCl 50 MG Oral Tablet	PSN	97f320c5-aa0b-43a8-85e8-c277a5929d97	3
312941	sertraline 50 MG Oral Tablet	SCD	97f320c5-aa0b-43a8-85e8-c277a5929d97	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	97f320c5-aa0b-43a8-85e8-c277a5929d97	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9655-05	00143965505	500 TABLET, FILM COATED in 1 BOTTLE (0143-9655-05)	2012-11-06	0000-00-00	No	No	Current
0143-9655-09	00143965509	90 TABLET, FILM COATED in 1 BOTTLE (0143-9655-09)	2012-11-06	0000-00-00	No	No	Current
0143-9655-30	00143965530	30 TABLET, FILM COATED in 1 BOTTLE (0143-9655-30)	2012-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Tablets, USP 50 mg Iss. 09/12 Rx Only	ReadyMeds	2014-05-15	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Tablets, USP 25 mg, 50 mg and 100 mg Iss. 09/12 Rx Only	Hikma Pharmaceuticals USA Inc.	2013-05-29	HUMAN PRESCRIPTION DRUG LABEL	3