SERTRALINE HYDROCHLORIDE

Product NDC: 71093-143
Requested package NDC: 71093-143-11
11-digit product format: 710930143
Labeler code: 71093
Product ID: 71093-143_ecd3e16c-dc4b-42f1-8213-9ce013299901
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SERTRALINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: ACI Healthcare USA, Inc.
Application: ANDA076934
Marketing category: ANDA
Marketing start: 2006-06-30
Marketing end: 0000-00-00
Substance: SERTRALINE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

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

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71093-143	71093-143-11	I	Inactivated by FDA		2026-08-17

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076934-001	SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA		2006-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076934-001	AA

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 2 · 42 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	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL		2006-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL		2006-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL		2006-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL		2006-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL		2006-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076934-001	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE / ORAL	AA	2006-06-30	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076934-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076934-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076934-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076934-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076934-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076934-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076934-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076934-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076934-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076934-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076934-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076934-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076934-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076934-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076934-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076934-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076934-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076934-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A076934-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076934-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076934-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076934-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076934-001	AA	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076934-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076934-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076934-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076934-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076934-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076934-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076934-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076934-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076934-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076934-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076934-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076934-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076934-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076934-001	AA	1	`a50c72e98297…`

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	Strength	SPL version
71093-143-11	SERTRALINE HYDROCHLORIDE	60 mL in 1 BOTTLE, DROPPER	SOLUTION	60		8
71093-143-11	SERTRALINE HYDROCHLORIDE	1 in 1 CARTON	SOLUTION	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71093-143	SERTRALINE HYDROCHLORIDE SOLUTION [ACI HEALTHCARE USA, INC.]	8	Legacy NDC, 2 package rows	20231218_f5da1754-2aed-4777-ad2e-593ee43e6e86.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	fa260c6c-9f6a-46a3-91ce-5665739d87e7	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076934 application number: ANDA076934

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
861064	sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution	PSN	fa260c6c-9f6a-46a3-91ce-5665739d87e7	106
861064	sertraline 20 MG/ML Oral Solution	SCD	fa260c6c-9f6a-46a3-91ce-5665739d87e7	106
861064	sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution	SY	fa260c6c-9f6a-46a3-91ce-5665739d87e7	106
861064	sertraline HCl 20 MG in 1 mL Concentrate for Oral Solution	PSN	f5da1754-2aed-4777-ad2e-593ee43e6e86	8
861064	sertraline 20 MG/ML Oral Solution	SCD	f5da1754-2aed-4777-ad2e-593ee43e6e86	8
861064	sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral Solution	SY	f5da1754-2aed-4777-ad2e-593ee43e6e86	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71093-143-11	71093014311	1 BOTTLE, DROPPER in 1 CARTON (71093-143-11) > 60 mL in 1 BOTTLE, DROPPER	2018-08-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SERTRALINE HYDROCHLORIDE	Bryant Ranch Prepack	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	106
SERTRALINE HYDROCHLORIDE	ACI Healthcare USA, Inc. \| ACI HealthCare Limited \| InvaTech Pharma Solutions LLC.	2023-12-17	HUMAN PRESCRIPTION DRUG LABEL	8