ROPINIROLE HYDROCHLORIDE

Product NDC
64679-171
11-digit product format
646790171
Labeler code
64679
Product ID
64679-171_e5aa4d3e-9925-4d24-93ed-69a16f88601c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA079050
Marketing category
ANDA
Marketing start
2008-05-29
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64679-171DDiscontinued by firm2026-08-07
excluded packagepackage64679-17164679-171-01DDiscontinued by firm2026-08-07
excluded packagepackage64679-17164679-171-02DDiscontinued by firm2026-08-07
excluded packagepackage64679-17164679-171-03DDiscontinued by firm2026-08-07
excluded packagepackage64679-17164679-171-04DDiscontinued by firm2026-08-07

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 2 · 105 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-171-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-171-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-171-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-171-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-171-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-171-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-171-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-171-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-171-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-171-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-171-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-171-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-171-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-171-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-171-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-171-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-171-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-171-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-171-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-171-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-171-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-171-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-171-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-171-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-171-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-171-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-171-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-171-04DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-171-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-171-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-171-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-171-04DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-171-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-171-03DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-171-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-171-04DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-171-04IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-171-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-171-03IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-171-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-171-04IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-171-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-171-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-171-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-171-04IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-171-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-171-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-171-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A079050-001ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-29
A079050-002ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-29
A079050-003ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-29
A079050-004ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-29
A079050-005ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-29
A079050-006ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-29
A079050-007ROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079050-001AB
A079050-002AB
A079050-003AB
A079050-004AB
A079050-005AB
A079050-006AB
A079050-007AB

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 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-006ROPINIROLE HYDROCHLORIDEEQ 4MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-007ROPINIROLE HYDROCHLORIDEEQ 5MG BASETABLET / ORALAB2008-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079050-001ROPINIROLE HYDROCHLORIDEEQ 0.25MG BASETABLET / ORALAB2008-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079050-002ROPINIROLE HYDROCHLORIDEEQ 0.5MG BASETABLET / ORALAB2008-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079050-003ROPINIROLE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB2008-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079050-004ROPINIROLE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB2008-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079050-005ROPINIROLE HYDROCHLORIDEEQ 3MG BASETABLET / ORALAB2008-05-2903ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079050-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079050-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079050-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079050-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079050-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079050-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079050-004AB1b8a1b40f171c…
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
64679-171-012024-11-15These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-022024-11-15These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-032024-11-15These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-042024-11-15These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-012020-01-31These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-022020-01-31These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-032020-01-31These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
64679-171-042020-01-31These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-171-02EA - Each64679-171d2edb238-f777-466d-8f7e-a69ec3e9bd7212012-07-24
64679-171-03EA - Each64679-1715f1ac8cb-e585-473c-965c-5549fecddbe912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CARMINIC ACIDINACTIVE INGREDIENTCID8Z8N95NROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2