Sertraline Hydrochloride

Product NDC: 68180-351
11-digit product format: 681800351
Labeler code: 68180
Product ID: 68180-351_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: 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 1.

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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077670-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077670-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077670-001	AB	1	`8072bd15b7f6…`

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	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
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
68180-351-01	Sertraline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	28
68180-351-03	Sertraline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	28
68180-351-06	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	28
68180-351-08	Sertraline Hydrochloride	50 in 1 BOTTLE	TABLET, FILM COATED	50	28
68180-351-09	Sertraline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-351-03	EA - Each	68180-351	92479140-91be-43e4-8f4c-3e7c91d2872e	1	2018-04-19
68180-351-06	EA - Each	68180-351	e26e707c-bf86-462f-9b93-756a97f6be68	1	2012-07-24
68180-351-09	EA - Each	68180-351	c907f61b-c9b9-4d09-add5-a44e1a6626ed	1	2012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-351	SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]	24	Current NDC, Legacy NDC, 5 package rows	20250501_42120ff8-b353-4632-9ea9-54de9a698724.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 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 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
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	A-S Medication Solutions	0de9e3e3-912a-428b-89d2-70811a56cdc5	2025-10-15	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
312940	sertraline HCl 25 MG Oral Tablet	PSN	cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6	15
312940	sertraline 25 MG Oral Tablet	SCD	cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6	15
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6	15
312940	sertraline HCl 25 MG Oral Tablet	PSN	e93391c9-db88-4fa5-b1d5-f6c6de78b31c	11
312940	sertraline 25 MG Oral Tablet	SCD	e93391c9-db88-4fa5-b1d5-f6c6de78b31c	11
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	e93391c9-db88-4fa5-b1d5-f6c6de78b31c	11
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
312938	sertraline HCl 100 MG Oral Tablet	PSN	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline HCl 25 MG Oral Tablet	PSN	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline HCl 25 MG Oral Tablet	PSN	f515d1e7-5803-4797-b3cc-8dbea85d96e5	8
312941	sertraline HCl 50 MG Oral Tablet	PSN	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312938	sertraline 100 MG Oral Tablet	SCD	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline 25 MG Oral Tablet	SCD	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline 25 MG Oral Tablet	SCD	f515d1e7-5803-4797-b3cc-8dbea85d96e5	8
312941	sertraline 50 MG Oral Tablet	SCD	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	f515d1e7-5803-4797-b3cc-8dbea85d96e5	8
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	4cf8d5c8-842b-4e7c-9a99-3f41ef8abbdb	8
312938	sertraline HCl 100 MG Oral Tablet	PSN	10baaffd-061e-d665-e063-6294a90a1594	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	3ee3a687-bbbf-4d17-8faf-33bc37328259	2
312940	sertraline HCl 25 MG Oral Tablet	PSN	10baaffd-061e-d665-e063-6294a90a1594	2
312941	sertraline HCl 50 MG Oral Tablet	PSN	10baaffd-061e-d665-e063-6294a90a1594	2
312938	sertraline 100 MG Oral Tablet	SCD	10baaffd-061e-d665-e063-6294a90a1594	2
312940	sertraline 25 MG Oral Tablet	SCD	10baaffd-061e-d665-e063-6294a90a1594	2
312940	sertraline 25 MG Oral Tablet	SCD	3ee3a687-bbbf-4d17-8faf-33bc37328259	2
312941	sertraline 50 MG Oral Tablet	SCD	10baaffd-061e-d665-e063-6294a90a1594	2
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	10baaffd-061e-d665-e063-6294a90a1594	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	10baaffd-061e-d665-e063-6294a90a1594	2
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	3ee3a687-bbbf-4d17-8faf-33bc37328259	2
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	10baaffd-061e-d665-e063-6294a90a1594	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-351-01	68180035101	100 TABLET, FILM COATED in 1 BOTTLE (68180-351-01)	2007-02-06	0000-00-00	No	No	Current
68180-351-03	68180035103	1000 TABLET, FILM COATED in 1 BOTTLE (68180-351-03)	2007-02-06	2028-03-31	No	No	Current
68180-351-06	68180035106	30 TABLET, FILM COATED in 1 BOTTLE (68180-351-06)	2007-02-06	2028-01-31	No	No	Current
68180-351-08	68180035108	50 TABLET, FILM COATED in 1 BOTTLE (68180-351-08)	2007-02-06	0000-00-00	No	No	Current
68180-351-09	68180035109	90 TABLET, FILM COATED in 1 BOTTLE (68180-351-09)	2007-02-06	2028-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride	Major Pharmaceuticals	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	9
Sertraline	REMEDYREPACK INC.	2026-03-17	HUMAN PRESCRIPTION DRUG LABEL	8
Sertraline	AvPAK	2026-01-12	HUMAN PRESCRIPTION DRUG LABEL	2
Sertraline Hydrochloride	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	28
Sertraline	A-S Medication Solutions	2024-10-23	HUMAN PRESCRIPTION DRUG LABEL	11
Sertraline	A-S Medication Solutions	2024-08-30	HUMAN PRESCRIPTION DRUG LABEL	15
Sertraline Hydrochloride Tablets USP 25 mg, 50 mg and 100 mg Rx Only	NCS HealthCare of KY, LLC dba Vangard Labs	2023-07-20	HUMAN PRESCRIPTION DRUG LABEL	7
Sertraline	REMEDYREPACK INC.	2023-04-19	HUMAN PRESCRIPTION DRUG LABEL	7
Sertraline Tablets USP 25 mg, 50 mg and 100 mg Rx Only	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	9
Sertraline	REMEDYREPACK INC.	2022-04-07	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride Tablets USP 25 mg, 50 mg and 100 mg Rx Only	TYA Pharmaceuticals	2014-08-01	HUMAN PRESCRIPTION DRUG LABEL	2