Sertraline

Product NDC: 63187-478
11-digit product format: 631870478
Labeler code: 63187
Product ID: 63187-478_820641b5-c569-4a24-b0a4-5d17d3cff8ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077670
Marketing category: ANDA
Marketing start: 2007-02-06
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	Approval date
A077670-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077670-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077670-003	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077670-001	AB
A077670-002	AB
A077670-003	AB

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077670-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077670-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077670-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077670-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077670-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077670-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077670-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077670-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077670-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077670-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077670-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077670-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077670-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077670-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sertraline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SERTRALINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UTI8907Y6X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312938	Internal RxNorm lookup
312940	Internal RxNorm lookup
312941	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
35dea1a2-ec26-4e52-8f09-ee4678e77946	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-478-30	Sertraline	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
63187-478-60	Sertraline	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
63187-478-90	Sertraline	90 in 1 BOTTLE	TABLET, FILM COATED	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-478-30	EA - Each	63187-478	57eed357-96f3-4f1f-b395-09fd78846253	1	2016-04-04
63187-478-90	EA - Each	63187-478	c9ffda5a-40fa-45f3-86b8-f624ed8400f9	1	2022-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SERTRALINE HYDROCHLORIDE	ACTIVE INGREDIENT	UTI8907Y6X	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
SERTRALINE	ACTIVE MOIETY	QUC7NX6WMB	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-478	SERTRALINE TABLET, FILM COATED [PROFICIENT RX LP]	9	Current NDC, Legacy NDC, 3 package rows	20221029_35dea1a2-ec26-4e52-8f09-ee4678e77946.zip

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	1b069fd8-26b9-459e-abfb-de28c012ddcb	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	a06f2cf6-ccef-47bf-aba8-a42bada46d8b	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	473d6055-b811-4ffb-9398-88f50a152196	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	42120ff8-b353-4632-9ea9-54de9a698724	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	AvPAK	40be43b2-649b-0928-e063-6394a90a3b48	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	NuCare Pharmaceuticals,Inc.	0a1f7d44-c339-a4dd-e063-6294a90ac0de	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	Quality Care Products, LLC	6ed2b9b7-e4af-4e28-a7d5-4ccb514af217	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	e93391c9-db88-4fa5-b1d5-f6c6de78b31c	2024-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	f5bf9595-d9f9-40b1-9b3b-da277fd5ab7f	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	b2533b60-cc54-4905-a4ee-ea08a160f8c6	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	A-S Medication Solutions	cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	NuCare Pharmaceuticals,Inc.	1ac8a624-2292-b7b8-e063-6394a90a165b	2024-06-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	Proficient Rx LP	35dea1a2-ec26-4e52-8f09-ee4678e77946	2022-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670 ndc (product): 63187-478

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UTI8907Y6X	SERTRALINE HYDROCHLORIDE	79559-97-0	SERTRALINE HYDROCHLORIDE
QUC7NX6WMB	SERTRALINE	79617-96-2	Sertraline

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312938	sertraline HCl 100 MG Oral Tablet	PSN	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312940	sertraline HCl 25 MG Oral Tablet	PSN	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312941	sertraline HCl 50 MG Oral Tablet	PSN	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312938	sertraline 100 MG Oral Tablet	SCD	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312940	sertraline 25 MG Oral Tablet	SCD	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312941	sertraline 50 MG Oral Tablet	SCD	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	35dea1a2-ec26-4e52-8f09-ee4678e77946	9
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	35dea1a2-ec26-4e52-8f09-ee4678e77946	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-478-30	63187047830	30 TABLET, FILM COATED in 1 BOTTLE (63187-478-30)	2015-05-01	0000-00-00	No	No	Current
63187-478-60	63187047860	60 TABLET, FILM COATED in 1 BOTTLE (63187-478-60)	2015-05-01	0000-00-00	No	No	Current
63187-478-90	63187047890	90 TABLET, FILM COATED in 1 BOTTLE (63187-478-90)	2015-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Tablets USP 25 mg, 50 mg and 100 mg Rx Only	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	9