Escitalopram Oral Solution

Product NDC: 68999-729
Requested package NDC: 68999-729-24
11-digit product format: 689990729
Labeler code: 68999
Product ID: 68999-729_499eac58-9e20-d82d-e063-6294a90a6b46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Escitalopram Oral
Dosage form: SOLUTION
Route: ORAL
Labeler: Chartwell Governmental & Specialty RX, LLC.
Application: ANDA090477
Marketing category: ANDA
Marketing start: 2023-06-12
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090477-001	ESCITALOPRAM OXALATE	EQ 5MG BASE/5ML	SOLUTION / ORAL	AA	2013-06-12	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090477-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090477-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090477-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090477-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090477-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090477-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090477-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090477-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090477-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090477-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090477-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090477-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090477-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090477-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090477-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090477-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090477-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090477-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090477-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090477-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090477-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090477-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090477-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090477-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090477-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090477-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090477-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090477-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090477-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090477-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090477-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090477-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090477-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090477-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090477-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090477-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090477-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090477-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090477-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090477-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Escitalopram Oral Solution
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
45ed4d16-6358-40a1-9352-319e58f55e5d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
04dce598-23c6-b7e7-c3dd-9b9cfd6e1615	Product name	6	20170718
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68999-729-10	Escitalopram Oral Solution	10 mL in 1 CUP	SOLUTION	10	1
68999-729-24	Escitalopram Oral Solution	2 in 1 BOX	SOLUTION	2	1
68999-729-24	Escitalopram Oral Solution	10 in 1 TRAY	SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68999-729-10	ML - Milliliter	68999-729	2f3a70d2-3877-442e-97ae-8766ff511b90	1	2026-03-17
68999-729-24	ML - Milliliter	68999-729	669b7654-5dd5-4078-83b5-a2333fe9139a	1	2026-03-17

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Escitalopram Oral Solution	ESCITALOPRAM ORAL	Chartwell Governmental & Specialty RX, LLC.	45ed4d16-6358-40a1-9352-319e58f55e5d	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090477 application number: ANDA090477 ndc (package): 68999-729-24 ndc (product): 68999-729 ndc11 (package): 68999072924
Escitalopram Oral Solution	ESCITALOPRAM ORAL	Chartwell RX, LLC	0458445b-e431-4c82-86b8-90373813c10a	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090477 application number: ANDA090477

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5U85DBW7LO	ESCITALOPRAM OXALATE	219861-08-2	ESCITALOPRAM OXALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
351285	escitalopram 5 MG in 5 mL Oral Solution	PSN	45ed4d16-6358-40a1-9352-319e58f55e5d	1
351285	escitalopram 1 MG/ML Oral Solution	SCD	45ed4d16-6358-40a1-9352-319e58f55e5d	1
351285	escitalopram (as escitalopram oxalate) 10 MG per 10 ML Oral Solution	SY	45ed4d16-6358-40a1-9352-319e58f55e5d	1
351285	escitalopram (as escitalopram oxalate) 5 MG per 5 ML Oral Solution	SY	45ed4d16-6358-40a1-9352-319e58f55e5d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68999-729-24	68999072924	2 TRAY in 1 BOX (68999-729-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-729-10)	2 tray	2026-01-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Escitalopram Oral Solution	Chartwell Governmental & Specialty RX, LLC.	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	1