Escitalopram Oxalate
- Product NDC
- 33342-038
- Requested package NDC
- 33342-038-12
- 11-digit product format
- 333420038
- Labeler code
- 33342
- Product ID
- 33342-038_53210109-53db-4d08-8ea4-be60e5597caf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Escitalopram Oxalate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202210
- Marketing category
- ANDA
- Marketing start
- 2012-09-11
- Substance
- ESCITALOPRAM OXALATE
- Active strength
- 20 mg/21
- 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 |
|---|---|---|---|---|---|---|---|
| A202210-001 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | |
| A202210-002 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | |
| A202210-003 | ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202210-001 | AB |
| A202210-002 | AB |
| A202210-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202210-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202210-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202210-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202210-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET / ORAL | AB | 2012-09-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-002 | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET / ORAL | AB | 2012-09-11 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-003 | 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 | A202210-001 | 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 | A202210-002 | 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 | A202210-003 | 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 | A202210-001 | ESCITALOPRAM OXALATE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-09-11 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202210-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202210-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202210-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202210-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202210-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202210-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202210-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202210-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202210-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202210-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202210-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202210-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202210-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202210-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202210-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202210-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202210-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202210-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202210-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202210-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202210-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202210-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202210-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202210-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202210-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202210-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202210-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202210-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202210-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202210-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202210-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202210-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202210-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202210-001 | AB | 1 | 301d65b070ca… |
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 Oxalate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESCITALOPRAM OXALATE | 20 mg/21 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5U85DBW7LO | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 04dce598-23c6-b7e7-c3dd-9b9cfd6e1615 | Product name | 6 | 20170718 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33342-038-11 | Escitalopram Oxalate | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 21 | |
| 33342-038-12 | Escitalopram Oxalate | 100 in 1 CARTON | TABLET, FILM COATED | 100 | 21 | |
| 33342-038-15 | Escitalopram Oxalate | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33342-038-11 | EA - Each | 33342-038 | 6ef0ee63-8a11-490e-bdba-87e16d730839 | 1 | 2014-02-04 |
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 OXALATE | A-S Medication Solutions | 76993020-6715-4090-847e-0fdcc5328f31 | 2024-07-31 | Boxed warning, Warnings, Adverse reactions | 202210 ANDA202210 |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | A-S Medication Solutions | c980262b-31f0-46df-902d-e593e1557fef | 2024-07-31 | Boxed warning, Warnings, Adverse reactions | 202210 ANDA202210 |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | NorthStar RxLLC | 81840aec-96fd-4af2-bd10-3f38d068f39a | 2024-07-05 | Boxed warning, Warnings, Adverse reactions | 202210 ANDA202210 |
| Escitalopram Oxalate | ESCITALOPRAM OXALATE | Macleods Pharmaceuticals Limited | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | 202210 ANDA202210 33342-038-12 33342-038 33342003812 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 349332 | escitalopram oxalate 10 MG Oral Tablet | PSN | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351250 | escitalopram oxalate 20 MG Oral Tablet | PSN | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351249 | escitalopram oxalate 5 MG Oral Tablet | PSN | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 349332 | escitalopram 10 MG Oral Tablet | SCD | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351250 | escitalopram 20 MG Oral Tablet | SCD | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351249 | escitalopram 5 MG Oral Tablet | SCD | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 349332 | escitalopram (as escitalopram oxalate) 10 MG Oral Tablet | SY | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351250 | escitalopram (as escitalopram oxalate) 20 MG Oral Tablet | SY | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
| 351249 | escitalopram (as escitalopram oxalate) 5 MG Oral Tablet | SY | 24b43cb4-1a26-44a2-b1d8-a40239eb5c7c | 21 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 33342-038-12 | 33342003812 | 100 TABLET, FILM COATED in 1 CARTON (33342-038-12) | 2012-09-11 | No | No | Current |