Home NDC 68180-137 Escitalopram
Product NDC 68180-137
11-digit product format 681800137
Labeler code 68180
Product ID 68180-137_a752cb19-7de3-4b6d-aa44-03b7027ea60b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitslopram
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA078169
Marketing category ANDA
Marketing start 2012-09-10
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 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Escitalopram
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESCITALOPRAM OXALATE 5 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 68180-137-01 Escitalopram 100 in 1 BOTTLE TABLET 100 21 68180-137-06 Escitalopram 30 in 1 BOTTLE TABLET 30 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-137 ESCITALOPRAM (ESCITSLOPRAM) TABLET [LUPIN PHARMACEUTICALS, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20231219_41f7392a-1f5c-4542-9c5c-f9e109851381.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-137-01 68180013701 100 TABLET in 1 BOTTLE (68180-137-01) 100 tablet 2012-09-10 0000-00-00 No No Current 68180-137-06 68180013706 30 TABLET in 1 BOTTLE (68180-137-06) 30 tablet 2012-09-10 0000-00-00 No No Current