Home NDC 0615-7953-39 Escitalopram
Product NDC 0615-7953
Requested package NDC 0615-7953-39
11-digit product format 006157953
Labeler code 0615
Product ID 0615-7953_3d9ca837-9178-4ec8-83aa-993cbc2a695a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitslopram
Dosage form TABLET
Route ORAL
Labeler NCS HealthCare of KY, Inc dba Vangard Labs
Application ANDA078169
Marketing category ANDA
Marketing start 2012-09-10
Marketing end 2022-05-31
Substance ESCITALOPRAM OXALATE
Active strength 5 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A078169-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 A078169-002 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 A078169-003 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11
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.
Product history page 1 of 4 · 126 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 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078169-002 ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078169-003 ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB 2012-09-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078169-001 ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB 2012-09-11 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Escitalopram ESCITSLOPRAM Lupin Pharmaceuticals, Inc. 41f7392a-1f5c-4542-9c5c-f9e109851381 2023-12-18 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078169 application number: ANDA078169
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0615-7953-39 00615795339 30 TABLET in 1 BLISTER PACK (0615-7953-39) 30 tablet 2016-04-14 2022-05-31 No No Current