ESCITALOPRAM TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2022-11-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:49:09

Label at a glance#

Productescitalopram
Active ingredientESCITALOPRAM OXALATE
Label structure2 sections

Label contents#

Full prescribing information#

SPL MEDGUIDE

SPL MEDGUIDE SECTION

Manufactured by:

Cadila Healthcare Ltd.

India.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1145-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 5 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 5 mg
Escitalopram Oxalate Tablets, 5 mg

NDC 70771-1146-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 10 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 10 mg
Escitalopram Oxalate Tablets, 10 mg

NDC 70771-1147-9 in bottle of 90 tablets

Escitalopram Oxalate Tablets USP, 20 mg

Rx only

90 tablets

Escitalopram Oxalate Tablets, 20 mg
Escitalopram Oxalate Tablets, 20 mg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1145ESCITALOPRAM TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Legacy NDC20221109_76d0e2a8-2ed2-4596-9179-8c360f4a0978.zip
70771-1146ESCITALOPRAM TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Legacy NDC20221109_76d0e2a8-2ed2-4596-9179-8c360f4a0978.zip
70771-1147ESCITALOPRAM TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]4Legacy NDC20221109_76d0e2a8-2ed2-4596-9179-8c360f4a0978.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077734-001ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11
A077734-002ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11
A077734-003ESCITALOPRAM OXALATEESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077734-001AB
A077734-002AB
A077734-003AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11c2088c7a36db…
2026-10-15 13:18:302026-09A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11c2088c7a36db…
2026-09-14 22:38:342026-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-09-14 22:38:342026-08A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1184e616aacf4f…
2026-08-18 06:07:402026-07A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-002ESCITALOPRAM OXALATEEQ 10MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-003ESCITALOPRAM OXALATEEQ 20MG BASETABLET / ORALAB2012-09-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-001ESCITALOPRAM OXALATEEQ 5MG BASETABLET / ORALAB2012-09-1179d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077734-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077734-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077734-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077734-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077734-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077734-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077734-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077734-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077734-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077734-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077734-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077734-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077734-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077734-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077734-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077734-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077734-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077734-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077734-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077734-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077734-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077734-001AB179d66fd596c7…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e669be99-2883-44c9-860e-4e142662294976d0e2a8-2ed2-4596-9179-8c360f4a09782025-08-14Exact identifier
spl set id: 76d0e2a8-2ed2-4596-9179-8c360f4a0978

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.