FDA.reportPublic FDA data

Sertraline HCl

Product NDC
60290-071
Requested package NDC
60290-071-01
11-digit product format
602900071
Labeler code
60290
Product ID
60290-071_593a87ef-14dc-60e8-e063-6394a90a4e8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA218342
Marketing category
ANDA
Marketing start
2026-02-15
Substance
SERTRALINE HYDROCHLORIDE
Active strength
200 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218342-001SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-20
A218342-002SERTRALINE HYDROCHLORIDESERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218342-001AB
A218342-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A218342-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-2084e616aacf4f…
2026-09-14 22:38:342026-08A218342-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-2084e616aacf4f…
2026-08-18 06:07:402026-07A218342-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-20caaa826d4ba7…
2026-08-18 06:07:402026-07A218342-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218342-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218342-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-20011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218342-001SERTRALINE HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2026-01-20a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218342-002SERTRALINE HYDROCHLORIDEEQ 200MG BASECAPSULE / ORALAB2026-01-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A218342-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A218342-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A218342-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A218342-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A218342-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218342-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218342-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218342-002AB1a50c72e98297…

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
Sertraline HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE200 mg/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251201Internal RxNorm lookup
410584Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a6d0f35c-f4f4-456d-b8d9-d56297261ad6Available on FDA.report

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 HClSERTRALINE HYDROCHLORIDEUmedica Laboratories USA Inc.a6d0f35c-f4f4-456d-b8d9-d56297261ad62026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218342
application number: ANDA218342
ndc (package): 60290-071-01
ndc (product): 60290-071
ndc11 (package): 60290007101
Sertraline HClSERTRALINE HYDROCHLORIDEBiocon Pharma Inc.623b9672-b41e-4ec9-b2cc-f5bb383c39ba2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218342
application number: ANDA218342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-071-016029000710130 CAPSULE in 1 BOTTLE (60290-071-01) 30 capsule2026-02-15NoNoCurrent