Home NDC 43602-474 ESCITALOPRAM OXALATE
Product NDC 43602-474
11-digit product format 436020474
Labeler code 43602
Product ID 43602-474_c891ea0b-ed9d-4e75-a529-2b8a651034d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name escitalopram
Dosage form TABLET
Route ORAL
Labeler Ascent Pharmaceuticals, Inc
Application ANDA215177
Marketing category ANDA
Marketing start 2025-07-15
Substance ESCITALOPRAM OXALATE
Active strength 10 mg/1
Pharmacologic classes 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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215177-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 A215177-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 A215177-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 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 A215177-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215177-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215177-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215177-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215177-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215177-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215177-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215177-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215177-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215177-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215177-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215177-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215177-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2025-07-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215177-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2025-07-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215177-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2025-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ESCITALOPRAM OXALATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCITALOPRAM OXALATE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5U85DBW7LO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349332 Internal RxNorm lookup 351249 Internal RxNorm lookup 351250 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43602-474-10 ESCITALOPRAM OXALATE 1000 in 1 BOTTLE TABLET 1000 1 43602-474-30 ESCITALOPRAM OXALATE 30 in 1 BOTTLE TABLET 30 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43602-474-10 43602047410 1000 TABLET in 1 BOTTLE (43602-474-10) 1000 tablet 2025-07-15 No No Current 43602-474-30 43602047430 30 TABLET in 1 BOTTLE (43602-474-30) 30 tablet 2025-07-15 No No Current