Home NDC 0480-9741 lisdexamfetamine dimesylate
Product NDC 0480-9741
11-digit product format 004809741
Labeler code 0480
Product ID 0480-9741_a9418850-010a-4fff-9aa7-d7167d58d8b6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lisdexamfetamine dimesylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA215415
Marketing category ANDA
Marketing start 2024-09-16
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A215415-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2023-08-25 A215415-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2023-08-25 A215415-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2023-08-25 A215415-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2023-08-25 A215415-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2023-08-25 A215415-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / 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.
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 2026-08-01 22:54:32 2026-06 A215415-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A215415-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A215415-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A215415-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A215415-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A215415-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2023-08-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
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 1871456 Internal RxNorm lookup 1871460 Internal RxNorm lookup 1871462 Internal RxNorm lookup 1871464 Internal RxNorm lookup 1871466 Internal RxNorm lookup 1871468 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 0480-9741-01 lisdexamfetamine dimesylate 100 in 1 BOTTLE TABLET, CHEWABLE 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-9741 LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20240918_bdb03bfa-0398-41e5-8e73-ded696cbca32.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0480-9741-01 00480974101 100 TABLET, CHEWABLE in 1 BOTTLE (0480-9741-01) 2024-09-16 No No Current