Home NDC 0143-9655-30 Sertraline
Product NDC 0143-9655
Requested package NDC 0143-9655-30
11-digit product format 001439655
Labeler code 0143
Product ID 0143-9655_f35de481-61af-428e-abb4-a267238b3959
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA077864
Marketing category ANDA
Marketing start 2012-11-06
Marketing end 0000-00-00
Substance SERTRALINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A077864-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 A077864-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 A077864-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10
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 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077864-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2009-08-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077864-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2009-08-10 1e350fbaab3a…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [READYMEDS] 3 SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [WEST-WARD PHARMACEUTICAL CORP] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0143-9655-30 00143965530 30 TABLET, FILM COATED in 1 BOTTLE (0143-9655-30) 2012-11-06 0000-00-00 No No Current