Home NDC 69097-438 Sertraline Hydrochloride
Product NDC 69097-438
11-digit product format 690970438
Labeler code 69097
Product ID 69097-438_d93baba8-ca39-4dd5-bcda-5def49b56e2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertraline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Cipla USA Inc.
Application ANDA218853
Marketing category ANDA
Marketing start 2025-07-17
Substance SERTRALINE HYDROCHLORIDE
Active strength 150 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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218853-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 A218853-002 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A218853-001 CGT 2026-01-18 A218853-002 CGT 2026-01-18
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.
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 2026-09-14 22:38:34 2026-08 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218853-001 SERTRALINE HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-07-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218853-002 SERTRALINE HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-07-16 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SERTRALINE HYDROCHLORIDE 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 251201 Internal RxNorm lookup 410584 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 69097-438-02 Sertraline Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1
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 Units Marketing start Sample Exclude flag Status 69097-438-02 69097043802 30 CAPSULE in 1 BOTTLE (69097-438-02) 30 capsule 2025-07-17 No No Current