Home NDC 59762-0067 Sertraline hydrochloride
Product NDC 59762-0067
11-digit product format 597620067
Labeler code 59762
Product ID 59762-0067_a0edcebe-af2d-463c-aad8-fa5fb77f0828
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sertraline hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020990
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-05-15
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 N020990-001 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020990-001 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 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020990-001 6727283 2019-10-11 U-580 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020990-001 7067555 2019-10-11 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020990-001 6727283*PED 2020-04-11 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020990-001 7067555*PED 2020-04-11 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N020990-001 6727283*PED 2020-04-11 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020990-001 7067555*PED 2020-04-11 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020990-001 6727283*PED 2020-04-11 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020990-001 7067555*PED 2020-04-11 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020990-001 6727283 2019-10-11 U-580 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020990-001 7067555 2019-10-11 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020990-001 6727283*PED 2020-04-11 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020990-001 7067555*PED 2020-04-11 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020990-001 6727283 2019-10-11 U-580 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020990-001 7067555 2019-10-11 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020990-001 6727283*PED 2020-04-11 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020990-001 7067555*PED 2020-04-11 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020990-001 6727283 2019-10-11 U-580 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020990-001 7067555 2019-10-11 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020990-001 6727283*PED 2020-04-11 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020990-001 7067555*PED 2020-04-11 Pediatric extension ea99ee380514…
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 59762-0067-1 Sertraline hydrochloride 1 in 1 CARTON SOLUTION, CONCENTRATE 1 41 59762-0067-1 Sertraline hydrochloride 60 mL in 1 BOTTLE, DROPPER SOLUTION, CONCENTRATE 60 41
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 SERTRALINE ACTIVE MOIETY QUC7NX6WMB SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SERTRALINE HYDROCHLORIDE TABLET, FILM COATED SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [GREENSTONE LLC] 24
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0067 SERTRALINE HYDROCHLORIDE SOLUTION, CONCENTRATE [MYLAN PHARMACEUTICALS INC.] 41 Current NDC, Legacy NDC, 2 package rows 20250504_1a58062b-e635-431a-908d-2651c6a4a21c.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 · 2 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 59762-0067-1 59762006701 1 BOTTLE, DROPPER in 1 CARTON (59762-0067-1) / 60 mL in 1 BOTTLE, DROPPER 2018-05-15 0000-00-00 No No Current