Home NDC 52427-664 sertraline HCl
Product NDC 52427-664
11-digit product format 524270664
Labeler code 52427
Product ID 52427-664_fee38eb1-855e-a3c0-c707-8665f61fb400
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Almatica Pharma LLC
Application NDA215133
Marketing category NDA
Marketing start 2021-10-04
Substance SERTRALINE HYDROCHLORIDE
Active strength 150 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215133-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2021-10-04 N215133-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD 2021-10-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 66 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 2026-02-19 14:30 UTC 2026-02 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2021-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD 2021-10-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2021-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD 2021-10-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2021-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD 2021-10-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD 2021-10-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD 2021-10-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD 2021-10-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD 2021-10-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD 2021-10-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215133-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL RLD, RS 2021-10-04 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215133-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL RLD 2021-10-04 6a51e52b5d6a…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base sertraline HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SERTRALINE HYDROCHLORIDE 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251201 Internal RxNorm lookup 410584 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 52427-664-30 sertraline HCl 30 in 1 BOTTLE CAPSULE 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-664 SERTRALINE HCL (SERTRALINE HYDROCHLORIDE) CAPSULE [ALMATICA PHARMA LLC] 4 Current NDC, Legacy NDC, 1 package rows 20241011_8c8bcba9-eaeb-aa44-f9ea-b580de55a439.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 · 2 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 52427-664-30 52427066430 30 CAPSULE in 1 BOTTLE (52427-664-30) 30 capsule 2021-11-01 0000-00-00 No No Current