Home NDC 50228-467 SERTRALINE HYDROCHLORIDE
Product NDC 50228-467
11-digit product format 502280467
Labeler code 50228
Product ID 50228-467_09a95635-597e-d608-e063-6294a90a203f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SERTRALINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ScieGen Pharmaceuticals Inc
Application ANDA076442
Marketing category ANDA
Marketing start 2023-05-08
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076442-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 A076442-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 A076442-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076442-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2007-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076442-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2007-04-30 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50228-467-05 SERTRALINE HYDROCHLORIDE 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 2 50228-467-30 SERTRALINE HYDROCHLORIDE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 2 50228-467-90 SERTRALINE HYDROCHLORIDE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50228-467 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS INC] 2 Current NDC, 3 package rows 20231109_10b9cae4-b452-4abb-866a-9f9d2568f212.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50228-467-05 50228046705 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-05) 2023-05-08 No No Current 50228-467-30 50228046730 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-30) 2023-05-08 No No Current 50228-467-90 50228046790 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50228-467-90) 2023-05-08 No No Current