Home NDC 0406-5127 Lisdexamfetamine Dimesylate
Product NDC 0406-5127
11-digit product format 004065127
Labeler code 0406
Product ID 0406-5127_b8fbbe5c-6972-454b-9738-4f4d8b2a7264
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisdexamfetamine Dimesylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler SpecGx LLC
Application ANDA218850
Marketing category ANDA
Marketing start 2024-12-17
Substance LISDEXAMFETAMINE DIMESYLATE
Active strength 40 mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218850-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 A218850-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 A218850-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 A218850-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 A218850-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 A218850-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17
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 2 · 54 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 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218850-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218850-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218850-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218850-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218850-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-17 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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 Lisdexamfetamine Dimesylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LISDEXAMFETAMINE DIMESYLATE 40 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0406-5127-01 Lisdexamfetamine Dimesylate 100 in 1 BOTTLE TABLET, CHEWABLE 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0406-5127 LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [SPECGX LLC] 4 Current NDC, 1 package rows 20241226_3a79b2ab-4131-4978-99a0-0119df57d5fe.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0406-5127-01 00406512701 100 TABLET, CHEWABLE in 1 BOTTLE (0406-5127-01) 2024-12-17 No No Current