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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020990-001ZOLOFTSERTRALINE HYDROCHLORIDEEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020990-001AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0784e616aacf4f…
2026-08-18 06:07:402026-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020990-001ZOLOFTEQ 20MG BASE/MLCONCENTRATE / ORALAARLD, RS1999-12-07f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020990-001AA184e616aacf4f…
2026-08-18 06:07:402026-07N020990-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020990-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020990-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020990-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020990-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020990-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020990-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020990-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020990-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020990-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020990-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020990-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020990-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020990-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020990-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020990-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020990-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020990-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020990-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020990-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020990-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020990-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N020990-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020990-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020990-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020990-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020990-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020990-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020990-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020990-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020990-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020990-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020990-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020990-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020990-001AA1f41ea6bd6efb…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020990-00167272832019-10-11U-580Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-00170675552019-10-11Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-0016727283*PED2020-04-11Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020990-0017067555*PED2020-04-11Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N020990-0016727283*PED2020-04-11Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020990-0017067555*PED2020-04-11Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020990-0016727283*PED2020-04-11Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020990-0017067555*PED2020-04-11Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020990-00167272832019-10-11U-580Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-00170675552019-10-11Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-0016727283*PED2020-04-11Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N020990-0017067555*PED2020-04-11Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N020990-00167272832019-10-11U-580Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-00170675552019-10-11Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-0016727283*PED2020-04-11Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N020990-0017067555*PED2020-04-11Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N020990-00167272832019-10-11U-580Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-00170675552019-10-11Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-0016727283*PED2020-04-11Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N020990-0017067555*PED2020-04-11Pediatric extensionea99ee380514…

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
IngredientStrength
SERTRALINE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
UTI8907Y6XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
208149Internal RxNorm lookup
208161Internal RxNorm lookup
212233Internal RxNorm lookup
312938Internal RxNorm lookup
312940Internal RxNorm lookup
312941Internal RxNorm lookup
861064Internal RxNorm lookup
861066Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fda754f6-d0f3-4dce-a17a-927d64f912f7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-601-35Zoloft60 mL in 1 BOTTLE, DROPPERSOLUTION, CONCENTRATE607
58151-601-35Zoloft1 in 1 CARTONSOLUTION, CONCENTRATE17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-601-35ML - Milliliter58151-601dc335571-efd1-4e99-ab0f-34d0dd7b1b3112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-601ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [VIATRIS SPECIALTY LLC]4Current NDC, 2 package rows20241206_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sertraline hydrochlorideSERTRALINE HYDROCHLORIDEMylan Pharmaceuticals Inc.1a58062b-e635-431a-908d-2651c6a4a21c2024-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020990
application number: NDA020990
ZoloftSERTRALINE HYDROCHLORIDEViatris Specialty LLCfda754f6-d0f3-4dce-a17a-927d64f912f72023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020990
application number: NDA020990
ndc (package): 58151-601-35
ndc (product): 58151-601
ndc11 (package): 58151060135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
861064sertraline HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
312940sertraline HCl 25 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
312941sertraline HCl 50 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
208149Zoloft 100 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
861066Zoloft 20 MG in 1 mL Concentrate for Oral SolutionPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
212233Zoloft 25 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
208161Zoloft 50 MG Oral TabletPSNfda754f6-d0f3-4dce-a17a-927d64f912f77
208149sertraline 100 MG Oral Tablet [Zoloft]SBDfda754f6-d0f3-4dce-a17a-927d64f912f77
861066sertraline 20 MG/ML Oral Solution [Zoloft]SBDfda754f6-d0f3-4dce-a17a-927d64f912f77
212233sertraline 25 MG Oral Tablet [Zoloft]SBDfda754f6-d0f3-4dce-a17a-927d64f912f77
208161sertraline 50 MG Oral Tablet [Zoloft]SBDfda754f6-d0f3-4dce-a17a-927d64f912f77
312938sertraline 100 MG Oral TabletSCDfda754f6-d0f3-4dce-a17a-927d64f912f77
861064sertraline 20 MG/ML Oral SolutionSCDfda754f6-d0f3-4dce-a17a-927d64f912f77
312940sertraline 25 MG Oral TabletSCDfda754f6-d0f3-4dce-a17a-927d64f912f77
312941sertraline 50 MG Oral TabletSCDfda754f6-d0f3-4dce-a17a-927d64f912f77
312938sertraline (as sertraline HCl) 100 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
312941sertraline (as sertraline HCl) 50 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
861064sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral SolutionSYfda754f6-d0f3-4dce-a17a-927d64f912f77
208149Zoloft (as sertraline hydrochloride) 100 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
861066Zoloft (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral SolutionSYfda754f6-d0f3-4dce-a17a-927d64f912f77
212233Zoloft (as sertraline hydrochloride) 25 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
208161Zoloft (as sertraline hydrochloride) 50 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
861066Zoloft 20 MG per 1 ML Concentrate for Oral SolutionSYfda754f6-d0f3-4dce-a17a-927d64f912f77
212233Zoloft 25 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77
208161Zoloft 50 MG Oral TabletSYfda754f6-d0f3-4dce-a17a-927d64f912f77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-601-35581510601351 BOTTLE, DROPPER in 1 CARTON (58151-601-35) / 60 mL in 1 BOTTLE, DROPPER2024-11-21NoNoCurrent