Home NDC 58151-601-35 Zoloft
Product NDC 58151-601
Requested package NDC 58151-601-35
11-digit product format 581510601
Labeler code 58151
Product ID 58151-601_fd27d2f5-1ade-4dbf-b2d2-bb98daf7da3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020990
Marketing category NDA
Marketing start 2024-11-21
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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N020990-001 ZOLOFT EQ 20MG BASE/ML CONCENTRATE / ORAL AA RLD, RS 1999-12-07 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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…
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 Zoloft
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 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208149 Internal RxNorm lookup 208161 Internal RxNorm lookup 212233 Internal RxNorm lookup 312938 Internal RxNorm lookup 312940 Internal RxNorm lookup 312941 Internal RxNorm lookup 861064 Internal RxNorm lookup 861066 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 58151-601-35 Zoloft 60 mL in 1 BOTTLE, DROPPER SOLUTION, CONCENTRATE 60 7 58151-601-35 Zoloft 1 in 1 CARTON SOLUTION, CONCENTRATE 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-601 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [VIATRIS SPECIALTY LLC] 4 Current NDC, 2 package rows 20241206_fda754f6-d0f3-4dce-a17a-927d64f912f7.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 Sample Exclude flag Status 58151-601-35 58151060135 1 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPER 2024-11-21 No No Current