Home DailyMed 1e1bf968-948e-458b-a02f-836662d6a08a National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:16:53
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021977-001 VYVANSE LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB RLD 2007-02-23 N021977-002 VYVANSE LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB RLD 2007-02-23 N021977-003 VYVANSE LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 N021977-004 VYVANSE LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB RLD 2007-12-10 N021977-005 VYVANSE LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB RLD 2007-12-10 N021977-006 VYVANSE LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB RLD 2007-12-10 N021977-007 VYVANSE LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB RLD 2014-10-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 8 · 308 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 2026-10-15 13:18:30 2026-09 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-006 VYVANSE 60MG CAPSULE / ORAL AB RLD 2007-12-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021977-007 VYVANSE 10MG CAPSULE / ORAL AB RLD 2014-10-30 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-006 VYVANSE 60MG CAPSULE / ORAL AB RLD 2007-12-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021977-007 VYVANSE 10MG CAPSULE / ORAL AB RLD 2014-10-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-006 VYVANSE 60MG CAPSULE / ORAL AB RLD 2007-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021977-007 VYVANSE 10MG CAPSULE / ORAL AB RLD 2014-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-006 VYVANSE 60MG CAPSULE / ORAL AB RLD 2007-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021977-007 VYVANSE 10MG CAPSULE / ORAL AB RLD 2014-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-006 VYVANSE 60MG CAPSULE / ORAL AB RLD 2007-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021977-007 VYVANSE 10MG CAPSULE / ORAL AB RLD 2014-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021977-001 VYVANSE 30MG CAPSULE / ORAL AB RLD 2007-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021977-002 VYVANSE 50MG CAPSULE / ORAL AB RLD 2007-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021977-003 VYVANSE 70MG CAPSULE / ORAL AB RLD, RS 2007-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021977-004 VYVANSE 20MG CAPSULE / ORAL AB RLD 2007-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021977-005 VYVANSE 40MG CAPSULE / ORAL AB RLD 2007-12-10 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 161 observed states.
Observed Orange Book patent history# Patent history page 1 of 126 · 5,002 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 N021977-001 7105486 2023-02-24 U-727 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7223735 2023-02-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7655630 2023-02-24 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7659253 2023-02-24 U-727 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7659254 2023-02-24 U-1034 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7662787 2023-02-24 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7662788 2023-02-24 U-727 2012-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7671030 2023-02-24 U-727 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7671031 2023-02-24 U-727 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7674774 2023-02-24 U-842 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7678770 2023-02-24 U-842 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7678771 2023-02-24 U-842 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7687466 2023-02-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7687467 2023-02-24 U-842 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7700561 2023-02-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7713936 2023-02-24 U-727 2012-02-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7718619 2023-02-24 U-842 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7723305 2023-02-24 U-842 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7105486*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7223735*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7655630*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7659253*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7659254*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7662787*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7662788*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7671030*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7671031*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7674774*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7678770*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7678771*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7687466*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7687467*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7700561*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7713936*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7718619*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-001 7723305*PED 2023-08-24 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-002 7105486 2023-02-24 U-727 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-002 7223735 2023-02-24 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-002 7655630 2023-02-24 Drug substance 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021977-002 7659253 2023-02-24 U-727 Drug substance, Drug product 5c6f7cd8ea54…
Observed Orange Book exclusivity history# 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 Vyvanse LISDEXAMFETAMINE DIMESYLATE Takeda Pharmaceuticals America, Inc. 704e4378-ca83-445c-8b45-3cfa51c1ecad 2026-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (package): 59417-104-10 ndc11 (package): 59417010410
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.