Home NDC 52817-224 Sertraline Hydrochloride
Product NDC 52817-224
11-digit product format 528170224
Labeler code 52817
Product ID 52817-224_c9e89324-0834-4434-8168-b4f2fa1e0a08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertraline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler TRUPHARMA, LLC
Application ANDA077713
Marketing category ANDA
Marketing start 2026-10-16
Substance SERTRALINE HYDROCHLORIDE
Active strength 200 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077713-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 A077713-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 A077713-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 A077713-004 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2026-09-25 A077713-005 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2026-09-25
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 · 134 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 2026-10-15 13:18:30 2026-09 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077713-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2026-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077713-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2026-09-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077713-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077713-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077713-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 d06236e962d9…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 200 mg/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 52817-224-90 52817022490 90 TABLET, FILM COATED in 1 BOTTLE (52817-224-90) 2026-10-16 No No Current