Sertraline Hydrochloride

Product NDC: 69097-834
11-digit product format: 690970834
Labeler code: 69097
Product ID: 69097-834_a0c9adca-e44e-4454-8eb5-7dc56b0b73b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sertraline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA077397
Marketing category: ANDA
Marketing start: 2016-07-21
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A077397-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-002	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06
A077397-003	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
A077397-001	AB
A077397-002	AB
A077397-003	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	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077397-001	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2007-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	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	A077397-001	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	A077397-002	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	A077397-003	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2007-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	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	A077397-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077397-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077397-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077397-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077397-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077397-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077397-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077397-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077397-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077397-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077397-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077397-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077397-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077397-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077397-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077397-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077397-001	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	50 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
cf71d1b9-5ebb-429f-a07f-a87cd168250f	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
69097-834-02	Sertraline Hydrochloride	30 in 1 BOTTLE	TABLET	30	10
69097-834-05	Sertraline Hydrochloride	90 in 1 BOTTLE	TABLET	90	10
69097-834-07	Sertraline Hydrochloride	100 in 1 BOTTLE	TABLET	100	10
69097-834-12	Sertraline Hydrochloride	500 in 1 BOTTLE	TABLET	500	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-834	SERTRALINE HYDROCHLORIDE TABLET [CIPLA USA INC.]	10	Current NDC, Legacy NDC, 4 package rows	20240310_cf71d1b9-5ebb-429f-a07f-a87cd168250f.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 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Coupler LLC	56442b06-c135-a035-e063-6394a90a171b	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Legacy Pharmaceutical Packaging, LLC	bd86b293-dab9-4d37-95eb-2bffca335d16	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	61835f25-bfe4-49ac-9dbf-3d6387866e78	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cipla USA Inc.	cf71d1b9-5ebb-429f-a07f-a87cd168250f	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397 ndc (product): 69097-834
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Northwind Health Company, LLC	ab30b0a4-6696-19da-e053-2995a90a29aa	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Cardinal Health 107, LLC	7e5e76cf-2fda-4f9d-bcbf-f77b1f188ee6	2025-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	52c88667-c67e-4d42-b319-afb354713b1e	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	2025-10-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	1548faf9-8625-f871-e063-6394a90a931f	2025-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	REMEDYREPACK INC.	7d598f1a-6c76-458a-a155-7a6a0743a2d3	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	30b94d67-0000-a045-e063-6394a90ade32	2025-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	American Health Packaging	4e09f580-d612-416c-a4a4-79a4411845b2	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7cadc747-5606-8efe-e053-2991aa0a1d8f	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	22c4b114-5f70-4c64-aa7f-b4169729b847	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	9bcef7ef-4e2f-4ab9-9c0f-f4956bfdd71b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
SERTRALINE	SERTRALINE	Aphena Pharma Solutions - Tennessee, LLC	7be6a62e-0e85-47c8-8793-b41c51c2557f	2024-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	787a683a-091c-4908-a643-ecbc8fd467eb	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	00179766-980b-44b0-99d3-1fee2bb27e37	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397
Sertraline Hydrochloride	SERTRALINE HYDROCHLORIDE	Proficient Rx LP	551d5946-00df-4608-96a2-b29f0ef93ba0	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077397 application number: ANDA077397

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	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312940	sertraline HCl 25 MG Oral Tablet	PSN	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312941	sertraline HCl 50 MG Oral Tablet	PSN	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312938	sertraline 100 MG Oral Tablet	SCD	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312940	sertraline 25 MG Oral Tablet	SCD	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312941	sertraline 50 MG Oral Tablet	SCD	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	44d9d754-f4da-4792-9e23-93faad0bffd1	22
312938	sertraline HCl 100 MG Oral Tablet	PSN	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312940	sertraline HCl 25 MG Oral Tablet	PSN	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312941	sertraline HCl 50 MG Oral Tablet	PSN	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	16
312941	sertraline HCl 50 MG Oral Tablet	PSN	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312938	sertraline 100 MG Oral Tablet	SCD	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312940	sertraline 25 MG Oral Tablet	SCD	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312941	sertraline 50 MG Oral Tablet	SCD	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312941	sertraline 50 MG Oral Tablet	SCD	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	16
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	adfcc867-1b6e-4698-94b6-2b4190c4ba3d	16
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	bd86b293-dab9-4d37-95eb-2bffca335d16	16
312938	sertraline HCl 100 MG Oral Tablet	PSN	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312938	sertraline HCl 100 MG Oral Tablet	PSN	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312940	sertraline HCl 25 MG Oral Tablet	PSN	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312940	sertraline HCl 25 MG Oral Tablet	PSN	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312941	sertraline HCl 50 MG Oral Tablet	PSN	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312941	sertraline HCl 50 MG Oral Tablet	PSN	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312938	sertraline 100 MG Oral Tablet	SCD	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312938	sertraline 100 MG Oral Tablet	SCD	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312940	sertraline 25 MG Oral Tablet	SCD	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312940	sertraline 25 MG Oral Tablet	SCD	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312941	sertraline 50 MG Oral Tablet	SCD	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312941	sertraline 50 MG Oral Tablet	SCD	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	d8102ff3-2b91-461d-9b99-f73443d8578d	10
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	cf71d1b9-5ebb-429f-a07f-a87cd168250f	10
312938	sertraline HCl 100 MG Oral Tablet	PSN	4e09f580-d612-416c-a4a4-79a4411845b2	7
312940	sertraline HCl 25 MG Oral Tablet	PSN	4e09f580-d612-416c-a4a4-79a4411845b2	7
312941	sertraline HCl 50 MG Oral Tablet	PSN	4e09f580-d612-416c-a4a4-79a4411845b2	7
312938	sertraline 100 MG Oral Tablet	SCD	4e09f580-d612-416c-a4a4-79a4411845b2	7
312940	sertraline 25 MG Oral Tablet	SCD	4e09f580-d612-416c-a4a4-79a4411845b2	7
312941	sertraline 50 MG Oral Tablet	SCD	4e09f580-d612-416c-a4a4-79a4411845b2	7
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	4e09f580-d612-416c-a4a4-79a4411845b2	7
312940	sertraline (as sertraline HCl) 25 MG Oral Tablet	SY	4e09f580-d612-416c-a4a4-79a4411845b2	7
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	4e09f580-d612-416c-a4a4-79a4411845b2	7
312938	sertraline HCl 100 MG Oral Tablet	PSN	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312941	sertraline HCl 50 MG Oral Tablet	PSN	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312938	sertraline 100 MG Oral Tablet	SCD	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312941	sertraline 50 MG Oral Tablet	SCD	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312938	sertraline (as sertraline HCl) 100 MG Oral Tablet	SY	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	2ff82f14-5035-4716-9372-ebc496cd34ec	4
312941	sertraline HCl 50 MG Oral Tablet	PSN	551d5946-00df-4608-96a2-b29f0ef93ba0	3
312941	sertraline HCl 50 MG Oral Tablet	PSN	549afcf3-69c3-396c-e054-00144ff8d46c	3
312941	sertraline HCl 50 MG Oral Tablet	PSN	2f7dea8d-9af7-4e56-a57a-8b6f81206219	3
312941	sertraline 50 MG Oral Tablet	SCD	551d5946-00df-4608-96a2-b29f0ef93ba0	3
312941	sertraline 50 MG Oral Tablet	SCD	549afcf3-69c3-396c-e054-00144ff8d46c	3
312941	sertraline 50 MG Oral Tablet	SCD	2f7dea8d-9af7-4e56-a57a-8b6f81206219	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	2f7dea8d-9af7-4e56-a57a-8b6f81206219	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	551d5946-00df-4608-96a2-b29f0ef93ba0	3
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	549afcf3-69c3-396c-e054-00144ff8d46c	3
312941	sertraline HCl 50 MG Oral Tablet	PSN	59287bc1-ac6f-47d2-84ba-b52f32f5894f	1
312941	sertraline 50 MG Oral Tablet	SCD	59287bc1-ac6f-47d2-84ba-b52f32f5894f	1
312941	sertraline (as sertraline HCl) 50 MG Oral Tablet	SY	59287bc1-ac6f-47d2-84ba-b52f32f5894f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-834-02	69097083402	30 TABLET in 1 BOTTLE (69097-834-02)	30 tablet	2016-07-21	0000-00-00	No	No	Current
69097-834-05	69097083405	90 TABLET in 1 BOTTLE (69097-834-05)	90 tablet	2016-07-21	0000-00-00	No	No	Current
69097-834-07	69097083407	100 TABLET in 1 BOTTLE (69097-834-07)	100 tablet	2016-07-21	0000-00-00	No	No	Current
69097-834-12	69097083412	500 TABLET in 1 BOTTLE (69097-834-12)	500 tablet	2016-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sertraline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	17
Sertraline Hydrochloride	Legacy Pharmaceutical Packaging, LLC	2026-03-11	HUMAN PRESCRIPTION DRUG LABEL	16
Sertraline Hydrochloride	Cipla USA Inc. \| InvaGen Pharmaceutical Inc \| InvaGen Pharmaceuticals, Inc \| Cipla Ltd.Kurkumbh, India \| Cipla Ltd. MIDC Patalganga, India	2026-02-01	HUMAN PRESCRIPTION DRUG LABEL	11
Sertraline Hydrochloride	American Health Packaging	2024-11-19	HUMAN PRESCRIPTION DRUG LABEL	7
Sertraline Hydrochloride	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	10
Sertraline Hydrochloride	REMEDYREPACK INC.	2022-05-17	HUMAN PRESCRIPTION DRUG LABEL	11
Sertraline Hydrochloride	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
Sertraline Tablets, USP 25mg, 50mg and 100 mg	NuCare Pharmaceuticals,Inc.	2022-01-28	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride	A-S Medication Solutions	2021-06-14	HUMAN PRESCRIPTION DRUG LABEL	22
Sertraline Tablets, USP 25mg, 50mg and 100 mg	NuCare Pharmaceuticals, Inc. \| NuCarePharmaceuticals, Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Tablets, USP 25mg, 50mg and 100 mg	Clinical Solutions Wholesale, LLC	2020-09-23	HUMAN PRESCRIPTION DRUG LABEL	6
Sertraline Hydrochloride	Preferred Pharmaceuticals Inc.	2019-11-13	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Tablets, USP 25mg, 50mg and 100 mg	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride	A-S Medication Solutions	2019-06-24	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride	Unit Dose Services	2019-03-06	HUMAN PRESCRIPTION DRUG LABEL	4
Sertraline Hydrochloride	REMEDYREPACK INC.	2019-01-16	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Hydrochloride	St. Mary's Medical Park Pharmacy \| ascent-pharmaceuticals-inc. \| InvaGen Pharmaceutical Inc	2018-11-16	HUMAN PRESCRIPTION DRUG LABEL	3
Sertraline Tablets, USP 25mg, 50mg and 100 mg	Aidarex Pharmaceuticals LLC	2016-11-29	HUMAN PRESCRIPTION DRUG LABEL	1
Sertraline - Northwind Pharmaceuticals, LLC	Northwind Pharmaceuticals, LLC	2016-11-11	HUMAN PRESCRIPTION DRUG LABEL	1