Home NDC 42291-041 Lisdexamfetamine Dimesylate
Product NDC 42291-041
11-digit product format 422910041
Labeler code 42291
Product ID 42291-041_36c401bd-e228-6fbd-e063-6394a90a5f1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisdexamfetamine
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA202830
Marketing category ANDA
Marketing start 2025-06-04
Substance LISDEXAMFETAMINE DIMESYLATE
Active strength 70 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202830-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 A202830-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 A202830-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 A202830-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 A202830-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 A202830-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202830-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202830-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202830-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202830-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202830-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lisdexamfetamine Dimesylate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISDEXAMFETAMINE DIMESYLATE 70 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SJT761GEGS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854830 Internal RxNorm lookup 854834 Internal RxNorm lookup 854838 Internal RxNorm lookup 854842 Internal RxNorm lookup 854846 Internal RxNorm lookup 854850 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-041-90 Lisdexamfetamine Dimesylate 90 in 1 BOTTLE CAPSULE 90 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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-041-90 42291004190 90 CAPSULE in 1 BOTTLE (42291-041-90) 90 capsule 2025-06-04 No No Current