Home NDC 0378-3857 Escitalopram Oxalate
Product NDC 0378-3857
11-digit product format 003783857
Labeler code 0378
Product ID 0378-3857_6404ddfe-f72d-4237-aea2-542cd677467e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name escitalopram
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021323
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2012-02-29
Marketing end 2020-01-31
Substance ESCITALOPRAM OXALATE
Active strength 20 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 126 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 2026-08-18 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-002 LEXAPRO EQ 10MG BASE TABLET / ORAL AB RLD 2002-08-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021323-003 LEXAPRO EQ 20MG BASE TABLET / ORAL AB RLD, RS 2002-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021323-001 LEXAPRO EQ 5MG BASE TABLET / ORAL AB RLD 2002-08-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 66 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 9 ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 3 ESCITALOPRAM OXALATE ACTIVE INGREDIENT 5U85DBW7LO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 ESCITALOPRAM ACTIVE MOIETY 4O4S742ANY ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESCITALOPRAM OXALATE (ESCITALOPRAM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lexapro ESCITALOPRAM Allergan, Inc. 13bb8267-1cab-43e5-acae-55a4d957630a 2023-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021323 application number: NDA021323
DailyMed RxNorm Mappings#