Home DailyMed a8eefc9e-a1d2-4dc7-b1ec-e350d793f642 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:25:45 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021323-001 LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 N021323-002 LEXAPRO ESCITALOPRAM OXALATE EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 N021323-003 LEXAPRO ESCITALOPRAM OXALATE EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N021323-001 NPP 2026-05-12 N021323-002 NPP 2026-05-12 N021323-003 NPP 2026-05-12
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 4 · 129 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 2026-09-14 22:38:34 2026-08 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 252 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-001 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-002 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 6916941 2022-08-12 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 7420069 2022-08-12 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 6916941*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021323-003 7420069*PED 2023-02-12 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021323-001 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-001 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-002 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 6916941 2022-08-12 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 7420069 2022-08-12 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 6916941*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021323-003 7420069*PED 2023-02-12 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021323-001 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-001 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-002 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 6916941 2022-08-12 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 7420069 2022-08-12 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 6916941*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021323-003 7420069*PED 2023-02-12 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021323-001 6916941 2022-08-12 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 7420069 2022-08-12 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 6916941*PED 2023-02-12 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021323-001 7420069*PED 2023-02-12 Pediatric extension 74a2ff9319b5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 69 observed states.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.