Home NDC 0049-0050 Zoloft
Product NDC 0049-0050
11-digit product format 000490050
Labeler code 0049
Product ID 0049-0050_842b5b3f-e0f0-4a16-bb47-2750a605452c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler ROERIG
Application NDA020990
Marketing category NDA
Marketing start 2017-01-06
Marketing end 2026-06-30
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
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…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0049-0050-01 Zoloft 60 mL in 1 BOTTLE, DROPPER SOLUTION, CONCENTRATE 60 68 0049-0050-01 Zoloft 1 in 1 CARTON SOLUTION, CONCENTRATE 1 68
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 SERTRALINE ACTIVE MOIETY QUC7NX6WMB ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-0050 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 66 Current NDC, Legacy NDC, 2 package rows 20241206_fe9e8b7d-61ea-409d-84aa-3ebd79a046b5.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 0049-0050-01 00049005001 1 BOTTLE, DROPPER in 1 CARTON (0049-0050-01) / 60 mL in 1 BOTTLE, DROPPER 2017-01-06 2026-06-30 No No Current