Sertraline Hydrochloride

Product NDC: 68180-992
11-digit product format: 681800992
Labeler code: 68180
Product ID: 68180-992_37fc8b27-bf23-4fe6-8d44-5331bde5b466
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA077670
Marketing category: ANDA
Marketing start: 2025-08-06
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 100 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 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	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 · 126 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
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077670-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SERTRALINE HYDROCHLORIDE	100 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
42120ff8-b353-4632-9ea9-54de9a698724	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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-992-01	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	28
68180-992-02	Sertraline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	28
68180-992-03	Sertraline Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	28
68180-992-04	Sertraline Hydrochloride	5000 in 1 BOTTLE	TABLET, FILM COATED	5000	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-992-01	EA - Each	68180-992	4d37f8ff-8065-475f-9653-f4b28d770826	1	2025-10-14
68180-992-02	EA - Each	68180-992	f144938c-2ec5-4b69-a296-19c05d36da61	1	2025-11-13
68180-992-03	EA - Each	68180-992	7fb6c9e9-150f-49d9-8093-db53448147ad	1	2025-10-14
68180-992-04	EA - Each	68180-992	4eab993e-1232-4e1b-aaf2-293c826e0052	1	2025-12-16

DailyMed Socrata Ingredients#

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

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f6346a11-88b9-4425-b08d-a22f19c4ceb4	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
SERTRALINE	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	7b5c29ff-25c8-4b68-844d-b8e95be7d09b	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Unit Dose Solutions, Inc.	55f514c6-f6ec-13ac-e063-6294a90ac957	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Major Pharmaceuticals	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	cac718b8-64bc-4aca-9b22-f2b00077bd41	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	268bd7f7-bc17-4850-ab7c-1b73caa564d5	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	4f94a6d7-8719-834c-e063-6294a90a3448	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	6c26a87a-b2b6-4302-bb8d-2031461f28ce	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	ddbf623f-8b6f-4e8d-87d3-dc890c0ab875	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	REMEDYREPACK INC.	c614be38-cb45-44a1-b78e-0cdfc0691618	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	REMEDYREPACK INC.	f515d1e7-5803-4797-b3cc-8dbea85d96e5	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	REMEDYREPACK INC.	e1864a7e-44b9-4399-9554-0c18b46fbdd6	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	b5e98b93-d8f8-4eed-8a0a-63b347b670ed	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	5f0616f6-433f-45c9-86f4-f802fda5d891	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
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 application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	AvPAK	10baaffd-061e-d665-e063-6294a90a1594	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	fd8a815e-88b7-4bef-9e32-6dbc735711a3	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline	SERTRALINE	REMEDYREPACK INC.	84aba223-04ae-479c-b5dd-e04fab45045d	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	345271ff-6a48-4888-a8d0-5a8ad60c7a21	2025-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077670 application number: ANDA077670

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
312938	sertraline HCl 100 MG Oral Tablet	PSN	42120ff8-b353-4632-9ea9-54de9a698724	28
312940	sertraline HCl 25 MG Oral Tablet	PSN	42120ff8-b353-4632-9ea9-54de9a698724	28
312941	sertraline HCl 50 MG Oral Tablet	PSN	42120ff8-b353-4632-9ea9-54de9a698724	28
312938	sertraline 100 MG Oral Tablet	SCD	42120ff8-b353-4632-9ea9-54de9a698724	28
312940	sertraline 25 MG Oral Tablet	SCD	42120ff8-b353-4632-9ea9-54de9a698724	28
312941	sertraline 50 MG Oral Tablet	SCD	42120ff8-b353-4632-9ea9-54de9a698724	28
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	42120ff8-b353-4632-9ea9-54de9a698724	28
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	42120ff8-b353-4632-9ea9-54de9a698724	28
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	42120ff8-b353-4632-9ea9-54de9a698724	28
312938	sertraline HCl 100 MG Oral Tablet	PSN	473d6055-b811-4ffb-9398-88f50a152196	9
312938	sertraline HCl 100 MG Oral Tablet	PSN	1b069fd8-26b9-459e-abfb-de28c012ddcb	9
312938	sertraline 100 MG Oral Tablet	SCD	1b069fd8-26b9-459e-abfb-de28c012ddcb	9
312938	sertraline 100 MG Oral Tablet	SCD	473d6055-b811-4ffb-9398-88f50a152196	9
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	473d6055-b811-4ffb-9398-88f50a152196	9
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	1b069fd8-26b9-459e-abfb-de28c012ddcb	9
312938	sertraline HCl 100 MG Oral Tablet	PSN	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312941	sertraline HCl 50 MG Oral Tablet	PSN	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312938	sertraline 100 MG Oral Tablet	SCD	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312940	sertraline 25 MG Oral Tablet	SCD	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312941	sertraline 50 MG Oral Tablet	SCD	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	fd92c8d3-17ec-477c-bc25-e5239c8606ac	2
312938	sertraline HCl 100 MG Oral Tablet	PSN	bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa	1
312938	sertraline HCl 100 MG Oral Tablet	PSN	ddbf623f-8b6f-4e8d-87d3-dc890c0ab875	1
312938	sertraline HCl 100 MG Oral Tablet	PSN	40be43b2-649b-0928-e063-6394a90a3b48	1
312940	sertraline HCl 25 MG Oral Tablet	PSN	40be43b2-649b-0928-e063-6394a90a3b48	1
312941	sertraline HCl 50 MG Oral Tablet	PSN	40be43b2-649b-0928-e063-6394a90a3b48	1
312938	sertraline 100 MG Oral Tablet	SCD	ddbf623f-8b6f-4e8d-87d3-dc890c0ab875	1
312938	sertraline 100 MG Oral Tablet	SCD	bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa	1
312938	sertraline 100 MG Oral Tablet	SCD	40be43b2-649b-0928-e063-6394a90a3b48	1
312940	sertraline 25 MG Oral Tablet	SCD	40be43b2-649b-0928-e063-6394a90a3b48	1
312941	sertraline 50 MG Oral Tablet	SCD	40be43b2-649b-0928-e063-6394a90a3b48	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	ddbf623f-8b6f-4e8d-87d3-dc890c0ab875	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	bdbcb3ce-e424-43eb-9f1a-77eda4dfbdaa	1
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	40be43b2-649b-0928-e063-6394a90a3b48	1
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	40be43b2-649b-0928-e063-6394a90a3b48	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	40be43b2-649b-0928-e063-6394a90a3b48	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68180-992-01	68180099201	30 TABLET, FILM COATED in 1 BOTTLE (68180-992-01)	2025-08-06	No	No	Current
68180-992-02	68180099202	90 TABLET, FILM COATED in 1 BOTTLE (68180-992-02)	2025-08-06	No	No	Current
68180-992-03	68180099203	500 TABLET, FILM COATED in 1 BOTTLE (68180-992-03)	2025-08-06	No	No	Current
68180-992-04	68180099204	5000 TABLET, FILM COATED in 1 BOTTLE (68180-992-04)	2025-08-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride	Bryant Ranch Prepack	2026-03-30	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride	REMEDYREPACK INC.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs \| LUPIN LIMITED	2026-01-23	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9
Sertraline Hydrochloride	A-S Medication Solutions	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	9
Sertraline Hydrochloride	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	28
Sertraline Hydrochloride	AvPAK	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	1