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 02:04:18

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-580-10EA - Each50458-58075f7a03f-e99c-4e0d-9e25-e899731889fc12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50458-58050458-580-10

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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022406-001XARELTORIVAROXABAN10MGTABLET / ORALABRLD2011-07-01
N022406-002XARELTORIVAROXABAN15MGTABLET / ORALABRLD2011-11-04
N022406-003XARELTORIVAROXABAN20MGTABLET / ORALABRLD, RS2011-11-04
N022406-004XARELTORIVAROXABAN2.5MGTABLET / ORALABRLD2018-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N022406-001AB
N022406-002AB
N022406-003AB
N022406-004AB

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022406-00195392182034-02-17U-19572017-02-07
N022406-00195392182034-02-17U-21432017-02-07
N022406-00195392182034-02-17U-26412017-02-07
N022406-00195392182034-02-17U-32882017-02-07
N022406-0019539218*PED2034-08-17Pediatric extension
N022406-00295392182034-02-17U-19532017-02-07
N022406-00295392182034-02-17U-32892017-02-07
N022406-0029539218*PED2034-08-17Pediatric extension
N022406-00395392182034-02-17U-19532017-02-07
N022406-00395392182034-02-17U-19542017-02-07
N022406-00395392182034-02-17U-19552017-02-07
N022406-00395392182034-02-17U-32852017-02-07
N022406-0039539218*PED2034-08-17Pediatric extension

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022406-001XARELTO10MGTABLET / ORALABRLD2011-07-0184e616aacf4f…
2026-09-14 22:38:342026-08N022406-002XARELTO15MGTABLET / ORALABRLD2011-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N022406-003XARELTO20MGTABLET / ORALABRLD, RS2011-11-0484e616aacf4f…
2026-09-14 22:38:342026-08N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-1184e616aacf4f…
2026-08-18 06:07:402026-07N022406-001XARELTO10MGTABLET / ORALABRLD2011-07-01caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-002XARELTO15MGTABLET / ORALABRLD2011-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-003XARELTO20MGTABLET / ORALABRLD, RS2011-11-04caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022406-001XARELTO10MGTABLET / ORALABRLD2011-07-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-002XARELTO15MGTABLET / ORALABRLD2011-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-003XARELTO20MGTABLET / ORALABRLD, RS2011-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-001XARELTO10MGTABLET / ORALABRLD2011-07-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-002XARELTO15MGTABLET / ORALABRLD2011-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-003XARELTO20MGTABLET / ORALABRLD, RS2011-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022406-001XARELTO10MGTABLET / ORALABRLD2011-07-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-002XARELTO15MGTABLET / ORALABRLD2011-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-003XARELTO20MGTABLET / ORALABRLD, RS2011-11-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-001XARELTO10MGTABLET / ORALRLD2011-07-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-002XARELTO15MGTABLET / ORALRLD2011-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-003XARELTO20MGTABLET / ORALRLD, RS2011-11-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-004XARELTO2.5MGTABLET / ORALABRLD2018-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-001XARELTO10MGTABLET / ORALRLD2011-07-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-002XARELTO15MGTABLET / ORALRLD2011-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-003XARELTO20MGTABLET / ORALRLD, RS2011-11-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-004XARELTO2.5MGTABLET / ORALRLD2018-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-001XARELTO10MGTABLET / ORALRLD2011-07-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-002XARELTO15MGTABLET / ORALRLD2011-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-003XARELTO20MGTABLET / ORALRLD, RS2011-11-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-004XARELTO2.5MGTABLET / ORALRLD2018-10-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022406-001XARELTO10MGTABLET / ORALRLD2011-07-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022406-002XARELTO15MGTABLET / ORALRLD2011-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022406-003XARELTO20MGTABLET / ORALRLD, RS2011-11-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022406-004XARELTO2.5MGTABLET / ORALRLD2018-10-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022406-001XARELTO10MGTABLET / ORALRLD2011-07-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022406-002XARELTO15MGTABLET / ORALRLD2011-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022406-003XARELTO20MGTABLET / ORALRLD, RS2011-11-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022406-004XARELTO2.5MGTABLET / ORALRLD2018-10-115bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022406-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022406-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N022406-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N022406-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N022406-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022406-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022406-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-004AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022406-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022406-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022406-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022406-004AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,783 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022406-00195392182034-02-17U-19572017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00195392182034-02-17U-26412017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00195392182034-02-17U-21432017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00195392182034-02-17U-32882017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-0019539218*PED2034-08-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022406-00295392182034-02-17U-19532017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00295392182034-02-17U-32892017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-0029539218*PED2034-08-17Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N022406-00395392182034-02-17U-19552017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00395392182034-02-17U-19542017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00395392182034-02-17U-19532017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-00395392182034-02-17U-32852017-02-0784e616aacf4f…
2026-09-14 22:38:342026-08N022406-0039539218*PED2034-08-17Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N022406-00195392182034-02-17U-19572017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00195392182034-02-17U-26412017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00195392182034-02-17U-21432017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00195392182034-02-17U-32882017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-0019539218*PED2034-08-17Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00295392182034-02-17U-19532017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00295392182034-02-17U-32892017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-0029539218*PED2034-08-17Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00395392182034-02-17U-19552017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00395392182034-02-17U-19542017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00395392182034-02-17U-19532017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-00395392182034-02-17U-32852017-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022406-0039539218*PED2034-08-17Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022406-00195392182034-02-17U-19572017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00195392182034-02-17U-26412017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00195392182034-02-17U-21432017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00195392182034-02-17U-32882017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-0019539218*PED2034-08-17Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00295392182034-02-17U-19532017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00295392182034-02-17U-32892017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-0029539218*PED2034-08-17Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00395392182034-02-17U-19552017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00395392182034-02-17U-19542017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00395392182034-02-17U-19532017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-00395392182034-02-17U-32852017-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022406-0039539218*PED2034-08-17Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-00171574562024-08-28U-1302Drug substance, Drug product2011-08-0431067a03dcf5…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 12 · 443 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-001I-8672024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-001PED2025-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-002I-8672024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-002PED2025-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-003I-8672024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-003PED2025-02-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-004I-8672024-08-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022406-004PED2025-02-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022406-001I-8672024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-001PED2025-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-002I-8672024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-002PED2025-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-003I-8672024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-003PED2025-02-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-004I-8672024-08-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022406-004PED2025-02-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-001I-8672024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-001PED2025-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-002I-8672024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-002PED2025-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-003I-8672024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-003PED2025-02-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-004I-8672024-08-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022406-004PED2025-02-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-001I-8672024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-001PED2025-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-002I-8672024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-002PED2025-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-003I-8672024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-003PED2025-02-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-004I-8672024-08-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022406-004PED2025-02-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-001I-8672024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-001PED2025-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-002I-8672024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-002PED2025-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-003I-8672024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-003PED2025-02-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-004I-8672024-08-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022406-004PED2025-02-2303ed91905a0d…

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
XareltoRIVAROXABANJanssen Pharmaceuticals, Inc.10db92f9-2300-4a80-836b-673e1ae916102026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 50458-580-10
ndc11 (package): 50458058010

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.