National Council for Prescription Drug Programs indexing - billing unit

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

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59417-104-10EA - Each59417-1041e1bf968-948e-458b-a02f-836662d6a08a12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59417-10459417-104-10

Source Document#

Source XML

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021977-001VYVANSELISDEXAMFETAMINE DIMESYLATE30MGCAPSULE / ORALABRLD2007-02-23
N021977-002VYVANSELISDEXAMFETAMINE DIMESYLATE50MGCAPSULE / ORALABRLD2007-02-23
N021977-003VYVANSELISDEXAMFETAMINE DIMESYLATE70MGCAPSULE / ORALABRLD, RS2007-02-23
N021977-004VYVANSELISDEXAMFETAMINE DIMESYLATE20MGCAPSULE / ORALABRLD2007-12-10
N021977-005VYVANSELISDEXAMFETAMINE DIMESYLATE40MGCAPSULE / ORALABRLD2007-12-10
N021977-006VYVANSELISDEXAMFETAMINE DIMESYLATE60MGCAPSULE / ORALABRLD2007-12-10
N021977-007VYVANSELISDEXAMFETAMINE DIMESYLATE10MGCAPSULE / ORALABRLD2014-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-productTE code
N021977-001AB
N021977-002AB
N021977-003AB
N021977-004AB
N021977-005AB
N021977-006AB
N021977-007AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-23c2088c7a36db…
2026-10-15 13:18:302026-09N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-23c2088c7a36db…
2026-10-15 13:18:302026-09N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-23c2088c7a36db…
2026-10-15 13:18:302026-09N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N021977-006VYVANSE60MGCAPSULE / ORALABRLD2007-12-10c2088c7a36db…
2026-10-15 13:18:302026-09N021977-007VYVANSE10MGCAPSULE / ORALABRLD2014-10-30c2088c7a36db…
2026-09-14 22:38:342026-08N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-2384e616aacf4f…
2026-09-14 22:38:342026-08N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N021977-006VYVANSE60MGCAPSULE / ORALABRLD2007-12-1084e616aacf4f…
2026-09-14 22:38:342026-08N021977-007VYVANSE10MGCAPSULE / ORALABRLD2014-10-3084e616aacf4f…
2026-08-18 06:07:402026-07N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-23caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-006VYVANSE60MGCAPSULE / ORALABRLD2007-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-007VYVANSE10MGCAPSULE / ORALABRLD2014-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-006VYVANSE60MGCAPSULE / ORALABRLD2007-12-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-007VYVANSE10MGCAPSULE / ORALABRLD2014-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-006VYVANSE60MGCAPSULE / ORALABRLD2007-12-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-007VYVANSE10MGCAPSULE / ORALABRLD2014-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021977-001VYVANSE30MGCAPSULE / ORALABRLD2007-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-002VYVANSE50MGCAPSULE / ORALABRLD2007-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-003VYVANSE70MGCAPSULE / ORALABRLD, RS2007-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-004VYVANSE20MGCAPSULE / ORALABRLD2007-12-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-005VYVANSE40MGCAPSULE / ORALABRLD2007-12-106a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 161 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09N021977-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-004AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-005AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-006AB1c2088c7a36db…
2026-10-15 13:18:302026-09N021977-007AB1c2088c7a36db…
2026-09-14 22:38:342026-08N021977-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-004AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-005AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-006AB184e616aacf4f…
2026-09-14 22:38:342026-08N021977-007AB184e616aacf4f…
2026-08-18 06:07:402026-07N021977-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021977-007AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021977-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021977-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021977-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021977-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021977-005AB16a471c1ec25d…

Observed Orange Book patent history#

Patent history page 1 of 126 · 5,002 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00171054862023-02-24U-7275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00172237352023-02-24Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176556302023-02-24Drug substance5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176592532023-02-24U-727Drug substance, Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176592542023-02-24U-10345c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176627872023-02-24Drug substance5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176627882023-02-24U-7272012-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176710302023-02-24U-727Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176710312023-02-24U-7275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176747742023-02-24U-842Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176787702023-02-24U-8425c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176787712023-02-24U-842Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176874662023-02-24Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00176874672023-02-24U-842Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00177005612023-02-24Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00177139362023-02-24U-7272012-02-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00177186192023-02-24U-842Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00177233052023-02-24U-842Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017105486*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017223735*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017655630*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017659253*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017659254*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017662787*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017662788*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017671030*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017671031*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017674774*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017678770*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017678771*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017687466*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017687467*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017700561*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017713936*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017718619*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-0017723305*PED2023-08-24Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00271054862023-02-24U-7275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00272237352023-02-24Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00276556302023-02-24Drug substance5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021977-00276592532023-02-24U-727Drug substance, Drug product5c6f7cd8ea54…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021977-001M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-002M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-003M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-004M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-005M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-006M-1882019-10-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021977-007M-1882019-10-1474a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021977-001M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-002M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-003M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-004M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-005M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-006M-1882019-10-143f01610625f2…
2019-12-14 00:12 UTC2019-12N021977-007M-1882019-10-143f01610625f2…
2019-09-15 20:21 UTC2019-09N021977-001M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-002M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-003M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-004M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-005M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-006M-1882019-10-14b00525d2431f…
2019-09-15 20:21 UTC2019-09N021977-007M-1882019-10-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N021977-001M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-002M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-003M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-004M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-005M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-006M-1882019-10-14ea99ee380514…
2019-07-19 19:46 UTC2019-07N021977-007M-1882019-10-14ea99ee380514…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VyvanseLISDEXAMFETAMINE DIMESYLATETakeda Pharmaceuticals America, Inc.704e4378-ca83-445c-8b45-3cfa51c1ecad2026-04-30Boxed warning, Warnings, Adverse reactionsExact 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.