Home NDC 65862-224 Sertraline Hydrochloride
Product NDC 65862-224
11-digit product format 658620224
Labeler code 65862
Product ID 65862-224_9bab5466-564e-4ce9-a139-0eb1ae02b6d1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertraline Hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA078861
Marketing category ANDA
Marketing start 2008-10-31
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 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078861-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078861-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078861-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2008-10-31 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sertraline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SERTRALINE HYDROCHLORIDE 20 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861064 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65862-224-20 Sertraline Hydrochloride 60 mL in 1 BOTTLE, PLASTIC SOLUTION, CONCENTRATE 60 27 65862-224-20 Sertraline Hydrochloride 1 in 1 CARTON SOLUTION, CONCENTRATE 1 27 65862-224-60 Sertraline Hydrochloride 1 in 1 CARTON SOLUTION, CONCENTRATE 1 27 65862-224-60 Sertraline Hydrochloride 60 mL in 1 BOTTLE SOLUTION, CONCENTRATE 60 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-224 SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [AUROBINDO PHARMA LIMITED] 27 Current NDC, Legacy NDC, 4 package rows 20240328_01800452-c353-4235-a66a-214048752e74.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65862-224-20 65862022420 1 BOTTLE, PLASTIC in 1 CARTON (65862-224-20) / 60 mL in 1 BOTTLE, PLASTIC 2008-10-31 0000-00-00 No No Current 65862-224-60 65862022460 1 BOTTLE in 1 CARTON (65862-224-60) / 60 mL in 1 BOTTLE 1 bottle 2008-10-31 0000-00-00 No No Current