Escitalopram oxalate
- Product NDC
- 76282-250
- Requested package NDC
- 76282-250-05
- 11-digit product format
- 762820250
- Labeler code
- 76282
- Product ID
- 76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- escitalopram
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA078604
- Marketing category
- ANDA
- Marketing start
- 2012-10-01
- Substance
- ESCITALOPRAM OXALATE
- Active strength
- 10 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078604-001 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | |
| A078604-002 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | |
| A078604-003 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078604-001 | AB |
| A078604-002 | AB |
| A078604-003 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078604-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078604-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | 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 | A078604-002 | 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 | A078604-003 | 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 | A078604-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078604-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078604-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078604-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078604-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078604-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078604-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078604-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078604-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078604-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078604-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078604-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078604-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078604-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078604-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078604-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078604-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078604-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078604-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078604-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078604-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078604-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078604-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078604-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078604-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078604-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078604-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078604-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078604-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078604-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078604-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078604-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078604-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078604-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078604-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078604-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078604-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078604-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078604-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078604-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Escitalopram oxalate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESCITALOPRAM OXALATE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5U85DBW7LO | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 04dce598-23c6-b7e7-c3dd-9b9cfd6e1615 | Product name | 6 | 20170718 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76282-250-01 | Escitalopram oxalate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 12 | |
| 76282-250-05 | Escitalopram oxalate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 12 | |
| 76282-250-10 | Escitalopram oxalate | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 12 | |
| 76282-250-30 | Escitalopram oxalate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 12 | |
| 76282-250-90 | Escitalopram oxalate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76282-250-10 | EA - Each | 76282-250 | 18eaae42-6683-49d5-9c87-ffd955e7be39 | 1 | 2014-01-04 |
| 76282-250-30 | EA - Each | 76282-250 | 63e04e8f-6657-4ad8-8ad7-90cd135bf6b2 | 1 | 2014-01-04 |
| 76282-250-90 | EA - Each | 76282-250 | 3fe15cc3-2ea2-43c0-ba35-f76f147651aa | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Escitalopram Oxalate | ESCITALOPRAM | REMEDYREPACK INC. | 4508226c-5623-41d3-8916-5f94ffdb8839 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078604 ANDA078604 |
| Escitalopram Oxalate | ESCITALOPRAM | Legacy Pharmaceutical Packaging, LLC | 9c68f89b-1d34-4735-9631-817f012935d7 | 2026-03-11 | Boxed warning, Warnings, Adverse reactions | 078604 ANDA078604 |
| Escitalopram Oxalate | ESCITALOPRAM | Cipla USA Inc. | 31ce0b82-58fe-44f3-8887-c55d8df1b773 | 2025-10-06 | Boxed warning, Warnings, Adverse reactions | 078604 ANDA078604 |
| Escitalopram oxalate | ESCITALOPRAM | Exelan Pharmaceuticals Inc. | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 078604 ANDA078604 76282-250-05 76282-250 76282025005 |
| Escitalopram oxalate | ESCITALOPRAM | Aphena Pharma Solutions - Tennessee, LLC | 900b7a2f-23e7-4c78-bd6e-549bbe09883e | 2021-04-21 | Boxed warning, Warnings, Adverse reactions | 078604 ANDA078604 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349332 | escitalopram oxalate 10 MG Oral Tablet | PSN | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351250 | escitalopram oxalate 20 MG Oral Tablet | PSN | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351249 | escitalopram oxalate 5 MG Oral Tablet | PSN | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 349332 | escitalopram 10 MG Oral Tablet | SCD | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351250 | escitalopram 20 MG Oral Tablet | SCD | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351249 | escitalopram 5 MG Oral Tablet | SCD | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 349332 | escitalopram (as escitalopram oxalate) 10 MG Oral Tablet | SY | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351250 | escitalopram (as escitalopram oxalate) 20 MG Oral Tablet | SY | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
| 351249 | escitalopram (as escitalopram oxalate) 5 MG Oral Tablet | SY | 8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 76282-250-05 | 76282025005 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05) | 2012-10-01 | 0000-00-00 | No | No | Current |