Mirapex

Product NDC
0597-0109
11-digit product format
005970109
Labeler code
0597
Product ID
0597-0109_52132628-35e3-4594-a642-da7162158112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pramipexole dihydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA022421
Marketing category
NDA
Marketing start
2010-02-22
Marketing end
0000-00-00
Substance
PRAMIPEXOLE DIHYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0597-0109DDiscontinued by firm2026-10-15
excluded packagepackage0597-01090597-0109-07DDiscontinued by firm2026-10-15
excluded packagepackage0597-01090597-0109-17DDiscontinued by firm2026-10-15
excluded packagepackage0597-01090597-0109-30DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 46 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0109-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0109-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0597-0109-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0109-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0109-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0597-0109-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0109-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0109-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0597-0109-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0109-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0109-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0597-0109-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0109-17cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0109-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0597-0109-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0109-17cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0109-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0597-0109-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0109-17302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0109-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0597-0109-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0109-17ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0109-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0597-0109-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0109-170efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0109-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0597-0109-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0109-17ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0109-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0597-0109-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0109-17367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0109-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0597-0109-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0109-17557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0597-0109-07557ba5c1ecfa…9c80585c8c6e…

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
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 · 308 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022421-001MIRAPEX ER0.375MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N022421-002MIRAPEX ER0.75MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N022421-003MIRAPEX ER1.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N022421-004MIRAPEX ER3MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N022421-005MIRAPEX ER4.5MGTABLET, EXTENDED RELEASE / ORALRLD2010-02-19c2088c7a36db…
2026-10-15 13:18:302026-09N022421-006MIRAPEX ER2.25MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17c2088c7a36db…
2026-10-15 13:18:302026-09N022421-007MIRAPEX ER3.75MGTABLET, EXTENDED RELEASE / ORALRLD2011-06-17c2088c7a36db…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-005AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-006AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022421-007AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022421-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-005AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-006AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022421-007AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022421-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-005AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-006AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022421-007AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-005AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-006AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022421-007AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-005AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-006AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022421-007AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-005AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022421-006AB1a67488948f0b…

Observed Orange Book patent history#

Patent history page 1 of 16 · 616 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N022421-00176957342028-04-26Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N022421-00186795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00276957342028-04-26Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N022421-00286795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00376957342028-04-26Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N022421-00386795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00476957342028-04-26Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N022421-00486795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00576957342028-04-26Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N022421-00586795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00676957342028-04-26Drug product2011-06-30c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00686795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00776957342028-04-26Drug product2011-06-30c2088c7a36db…
2026-10-15 13:18:302026-09N022421-00786795332029-09-08U-219Drug product2014-03-25c2088c7a36db…
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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0109-17EA - Each0597-010958ae3c0c-72f1-436b-85fa-6b71ff76293912012-07-24
0597-0109-30EA - Each0597-0109ea8f2a01-a8a0-4a77-a8dd-957825df527b12012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0597-0109-17005970109171 BOTTLE, PLASTIC in 1 CARTON (0597-0109-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2010-02-220000-00-00NoNoCurrent
0597-0109-30005970109301 BOTTLE, PLASTIC in 1 CARTON (0597-0109-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC2010-02-220000-00-00NoNoCurrent