Home NDC 63304-166 Sertraline Hydrochloride
Product NDC 63304-166
11-digit product format 633040166
Labeler code 63304
Product ID 63304-166_d75e7077-98f9-41d8-860c-39d556cc7a1b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertraline Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA077977
Marketing category ANDA
Marketing start 2007-02-06
Marketing end 0000-00-00
Substance SERTRALINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2019-12-31
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 3 · 126 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A077977-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 A077977-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 A077977-003 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 A077977-004 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 A077977-005 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06
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 6 · 220 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 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077977-001 SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077977-002 SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077977-003 SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077977-004 SERTRALINE HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077977-005 SERTRALINE HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL 2007-02-06 b8a1b40f171c…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-166-01 Sertraline Hydrochloride 100 in 1 BOTTLE TABLET, COATED 100 6 63304-166-03 Sertraline Hydrochloride 10 in 1 BOTTLE TABLET, COATED 10 6 63304-166-05 Sertraline Hydrochloride 500 in 1 BOTTLE TABLET, COATED 500 6 63304-166-30 Sertraline Hydrochloride 30 in 1 BOTTLE TABLET, COATED 30 6 63304-166-52 Sertraline Hydrochloride 2500 in 1 BOTTLE TABLET, COATED 2500 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-166 SERTRALINE HYDROCHLORIDE TABLET, COATED [RANBAXY PHARMACEUTICALS INC.] 6 Legacy NDC, 5 package rows 20160108_c25f968b-7037-4f60-9a02-2189769b0cbf.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 63304-166-01 63304016601 100 in 1 BOTTLE Historical 63304-166-03 63304016603 10 in 1 BOTTLE Historical 63304-166-05 63304016605 500 in 1 BOTTLE Historical 63304-166-30 63304016630 30 in 1 BOTTLE Historical 63304-166-52 63304016652 2500 in 1 BOTTLE Historical