Active ingredient
Escitalopram
155 finished FDA listings contain Escitalopram as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- ESCITALOPRAM OXALATE
- Dosage forms
- Capsule, Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 46
- Strengths listed
- 10 mg/1 · 10 mg/21 · 15 mg/1 · 20 mg/1 · 20 mg/21 · 5 mg/1 · 5 mg/5ml
- Brand names in FDA listings
- Escitalopram, Escitalopram Oral Solution, Escitalopram Oxalate, Lexapro
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 321988
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021323 | ABBVIE | 2002-08-14 | 3 |
| ANDA 202227 | AMNEAL PHARMS | 2012-03-14 | 1 |
| ANDA 079062 | AUROBINDO PHARMA LTD | 2012-04-02 | 2 |
| ANDA 079121 | SUN PHARMA CANADA | 2012-05-03 | 1 |
| ANDA 202221 | HETERO LABS LTD III | 2012-06-12 | 1 |
| ANDA 078604 | INVAGEN PHARMS | 2012-09-11 | 11 |
| ANDA 202210 | MACLEODS PHARMS LTD | 2012-09-11 | 8 |
| ANDA 078169 | CHARTWELL RX | 2012-09-11 | 1 |
| ANDA 090939 | TORRENT PHARMS LTD | 2012-09-11 | 23 |
| ANDA 090432 | AUROBINDO PHARMA LTD | 2012-09-11 | 21 |
| ANDA 202389 | ACCORD HLTHCARE | 2012-09-11 | 18 |
| ANDA 078777 | GRAVITI PHARMS | 2012-09-11 | 16 |
| ANDA 202280 | JUBILANT CADISTA | 2012-09-12 | 3 |
| ANDA 090477 | CHARTWELL MOLECULAR | 2013-06-12 | 2 |
| ANDA 078032 | PRINSTON INC | 2015-08-28 | 33 |
| ANDA 202754 | MACLEODS PHARMS LTD | 2016-03-31 | 1 |
| ANDA 205619 | AMNEAL PHARMS | 2017-05-17 | 6 |
| ANDA 215177 | ASCENT PHARMS INC | 2025-07-15 | 3 |
| NDA 219130 | ALMATICA | 2025-08-29 | 1 |
Official labeling on DailyMed
- ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.] · version 3 · 2026-09-07
- ESCITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.] · version 5 · 2026-09-02
- ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] · version 15 · 2026-07-27
- ESCITALOPRAM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-07-27
- ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-07-21
- ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 22 · 2026-07-20
- ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 104 · 2026-07-01
- ESCITALOPRAM TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 4 · 2026-07-01
- ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 105 · 2026-06-30
- ESCITALOPRAM (ESCITALOPRAM OXALATE) TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY] · version 2 · 2026-06-23
- ESCITALOPRAM TABLET, FILM COATED [BLUEPOINT LABORATORIES] · version 6 · 2026-06-17
- ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 101 · 2026-06-15
Showing the 12 most recent of 114 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.