Home NDC 51672-1348 Escitalopram
Product NDC 51672-1348
11-digit product format 516721348
Labeler code 51672
Product ID 51672-1348_38e51a59-5806-77a6-e063-6394a90af6c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Escitalopram Oxalate
Dosage form SOLUTION
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA079121
Marketing category ANDA
Marketing start 2012-05-03
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079121-001 ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL 2012-05-03
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 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL 2012-05-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL 2012-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL 2012-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079121-001 ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION / ORAL AA 2012-05-03 e64feba35796…
Observed Orange Book normalized TE history# 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/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351285 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Escitalopram Oxalate ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 Escitalopram ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 glycerin INACTIVE INGREDIENT PDC6A3C0OX ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 malic acid INACTIVE INGREDIENT 817L1N4CKP ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 methylparaben INACTIVE INGREDIENT A2I8C7HI9T ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 sorbitol INACTIVE INGREDIENT 506T60A25R ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8 water INACTIVE INGREDIENT 059QF0KO0R ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1348 ESCITALOPRAM (ESCITALOPRAM OXALATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.] 12 Current NDC, Legacy NDC, 6 package rows 20210703_c871d3fe-5ca2-410c-976d-9ec4b72c878f.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 51672-1348-1 51672134801 1 BOTTLE in 1 CARTON (51672-1348-1) / 240 mL in 1 BOTTLE 1 bottle 2012-05-03 0000-00-00 No No Current 51672-1348-8 51672134808 1 BOTTLE in 1 CARTON (51672-1348-8) / 120 mL in 1 BOTTLE 1 bottle 2012-05-03 0000-00-00 No No Current 51672-1348-9 51672134809 1 BOTTLE in 1 CARTON (51672-1348-9) / 480 mL in 1 BOTTLE 1 bottle 2012-05-03 0000-00-00 No No Current