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 01:17:36

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0116-30EA - Each0597-01161fa5d7e0-0cf9-417f-b575-416fa1bca2f612012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0597-01160597-0116-30

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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022421-001MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19
N022421-002MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19
N022421-003MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19
N022421-004MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19
N022421-005MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19
N022421-006MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17
N022421-007MIRAPEX ERPRAMIPEXOLE DIHYDROCHLORIDE3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022421-00176957342028-04-26Drug product
N022421-00186795332029-09-08U-219Drug product2014-03-25
N022421-00276957342028-04-26Drug product
N022421-00286795332029-09-08U-219Drug product2014-03-25
N022421-00376957342028-04-26Drug product
N022421-00386795332029-09-08U-219Drug product2014-03-25
N022421-00476957342028-04-26Drug product
N022421-00486795332029-09-08U-219Drug product2014-03-25
N022421-00576957342028-04-26Drug product
N022421-00586795332029-09-08U-219Drug product2014-03-25
N022421-00676957342028-04-26Drug product2011-06-30
N022421-00686795332029-09-08U-219Drug product2014-03-25
N022421-00776957342028-04-26Drug product2011-06-30
N022421-00786795332029-09-08U-219Drug product2014-03-25

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 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1984e616aacf4f…
2026-09-14 22:38:342026-08N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-1784e616aacf4f…
2026-09-14 22:38:342026-08N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-005AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-006AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022421-007AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-006AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022421-007AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-006AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022421-007AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022421-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-006AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022421-007AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022421-007AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022421-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022421-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022421-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022421-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022421-005AB15d02ea3f76ae…

Observed Orange Book patent history#

Patent history page 1 of 16 · 602 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022421-00176957342028-04-26Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022421-00186795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00276957342028-04-26Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022421-00286795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00376957342028-04-26Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022421-00386795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00476957342028-04-26Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022421-00486795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00576957342028-04-26Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N022421-00586795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00676957342028-04-26Drug product2011-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N022421-00686795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-09-14 22:38:342026-08N022421-00776957342028-04-26Drug product2011-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N022421-00786795332029-09-08U-219Drug product2014-03-2584e616aacf4f…
2026-08-18 06:07:402026-07N022421-00176957342028-04-26Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00186795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00276957342028-04-26Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00286795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00376957342028-04-26Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00386795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00476957342028-04-26Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00486795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00576957342028-04-26Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00586795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00676957342028-04-26Drug product2011-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00686795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00776957342028-04-26Drug product2011-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07N022421-00786795332029-09-08U-219Drug product2014-03-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022421-00176957342028-04-26Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00186795332029-09-08U-219Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00276957342028-04-26Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00286795332029-09-08U-219Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00376957342028-04-26Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00386795332029-09-08U-219Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00476957342028-04-26Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00486795332029-09-08U-219Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00576957342028-04-26Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00586795332029-09-08U-219Drug product2014-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00676957342028-04-26Drug product2011-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022421-00686795332029-09-08U-219Drug product2014-03-25011fe1cb6892…

Reported adverse events (FAERS/openFDA)#

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