Home NDC 54838-551-70 Escitalopram
Product NDC 54838-551
Requested package NDC 54838-551-70
11-digit product format 548380551
Labeler code 54838
Product ID 54838-551_5df0831c-c48f-47d9-a417-213b0f9bab23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA090477
Marketing category ANDA
Marketing start 2013-06-12
Marketing end 0000-00-00
Substance ESCITALOPRAM OXALATE
Active strength 5 mg/5mL
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090477-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090477-001 AA
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 2 · 42 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 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090477-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2013-06-12 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Escitalopram Oxalate ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 Escitalopram ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 glycerin INACTIVE INGREDIENT PDC6A3C0OX ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 methylparaben INACTIVE INGREDIENT A2I8C7HI9T ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 sorbitol INACTIVE INGREDIENT 506T60A25R ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6 water INACTIVE INGREDIENT 059QF0KO0R ESCITALOPRAM OXALATE SOLUTION [SILARX PHARMACEUTICALS, INC] 6
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54838-551-70 54838055170 240 mL in 1 BOTTLE, PLASTIC (54838-551-70) 240 ml 2013-06-12 0000-00-00 No No Current