Home NDC 0049-4940 Zoloft
Product NDC 0049-4940
11-digit product format 000494940
Labeler code 0049
Product ID 0049-4940_0a322518-ce09-4f78-a3a6-06359ff6df00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Roerig
Application NDA020990
Marketing category NDA
Marketing start 1992-02-11
Marketing end 0000-00-00
Substance SERTRALINE HYDR
Active strength 20 mg/mL
Pharmacologic classes Serotonin Reupt
NDC exclude flag No
Listing certified through 2020-12-31
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 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0049-4940-23 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0049-4940-23 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0049-4940-23 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0049-4940-23 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0049-4940-23 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0049-4940-23 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0049-4940-23 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0049-4940-23 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0049-4940-23 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0049-4940-23 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0049-4940-23 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0049-4940-23 557ba5c1ecfa…9c80585c8c6e…
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…
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.