Home NDC 63629-8774 SERTRALINE HYDROCHLORIDE
Product NDC 63629-8774
11-digit product format 636298774
Labeler code 63629
Product ID 63629-8774_10bafc5f-baec-4659-93f8-b0973a59304c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SERTRALINE HYDROCHLORIDE
Dosage form SOLUTION
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA076934
Marketing category ANDA
Marketing start 2006-06-30
Substance SERTRALINE HYDROCHLORIDE
Active strength 20 mg/mL
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076934-001 SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076934-001 AA
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 2 · 42 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 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL 2006-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076934-001 SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA 2006-06-30 e64feba35796…
Observed Orange Book normalized TE history# 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 20 mg/mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861064 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 63629-8774-1 SERTRALINE HYDROCHLORIDE 1 in 1 CARTON SOLUTION 1 106 63629-8774-1 SERTRALINE HYDROCHLORIDE 60 mL in 1 BOTTLE, DROPPER SOLUTION 60 106
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8774 SERTRALINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK] 106 Current NDC, Legacy NDC, 2 package rows 20240820_fa260c6c-9f6a-46a3-91ce-5665739d87e7.zip
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 Marketing start Marketing end Sample Exclude flag Status 63629-8774-1 63629877401 1 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER 2024-04-04 0000-00-00 No No Current