Home NDC 70010-214 Lisdexamfetamine dimesylate
Product NDC 70010-214
11-digit product format 700100214
Labeler code 70010
Product ID 70010-214_5b7f44b7-f69e-f96d-e063-6294a90a217a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lisdexamfetamine dimesylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application ANDA219258
Marketing category ANDA
Marketing start 2024-12-17
Substance LISDEXAMFETAMINE DIMESYLATE
Active strength 10 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 A219258-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 A219258-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 A219258-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 A219258-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 A219258-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 A219258-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16
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 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-005 LISDEXAMFETAMINE DIMESYLATE 50MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219258-006 LISDEXAMFETAMINE DIMESYLATE 60MG TABLET, CHEWABLE / ORAL AB 2024-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219258-001 LISDEXAMFETAMINE DIMESYLATE 10MG TABLET, CHEWABLE / ORAL AB 2024-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219258-002 LISDEXAMFETAMINE DIMESYLATE 20MG TABLET, CHEWABLE / ORAL AB 2024-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219258-003 LISDEXAMFETAMINE DIMESYLATE 30MG TABLET, CHEWABLE / ORAL AB 2024-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219258-004 LISDEXAMFETAMINE DIMESYLATE 40MG TABLET, CHEWABLE / ORAL AB 2024-12-16 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 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70010-214-01 Lisdexamfetamine dimesylate 100 in 1 BOTTLE TABLET, CHEWABLE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70010-214 LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [GRANULES PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20241219_c56b4712-2fb8-4c7a-bfbd-0401d9f5f92a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70010-214-01 70010021401 100 TABLET, CHEWABLE in 1 BOTTLE (70010-214-01) 2024-12-17 No No Current