Home NDC 0378-8011 Sertraline Hydrochloride
Product NDC 0378-8011
11-digit product format 003788011
Labeler code 0378
Product ID 0378-8011_cf8e87b3-0c39-43f4-a1ef-630b54df5ac6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc
Application ANDA078626
Marketing category ANDA
Marketing start 2013-05-29
Marketing end 2019-03-31
Substance SERTRALINE HYDR
Active strength 25 mg/1
Pharmacologic classes Serotonin Reupt
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A078626-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 A078626-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 A078626-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31
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 · 123 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 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078626-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2008-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078626-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2008-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078626-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2008-01-31 8072bd15b7f6…