Ropinirole
- Product NDC
- 60505-2866
- 11-digit product format
- 605052866
- Labeler code
- 60505
- Product ID
- 60505-2866_e54a4119-e45f-82c8-b676-91125578d7d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ropinirole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA079165
- Marketing category
- ANDA
- Marketing start
- 2013-03-29
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 60505-2866 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 60505-2866 | 60505-2866-1 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-3 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-5 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-6 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-7 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-8 | D | Discontinued by firm | 2026-08-10 | |
| excluded package | package | 60505-2866 | 60505-2866-9 | D | Discontinued by firm | 2026-08-10 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-6 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-7 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 60505-2866-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-6 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-7 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 60505-2866-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-6 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-7 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-9 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 60505-2866-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-6 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-7 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-9 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 60505-2866-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-6 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-7 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-9 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 60505-2866-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-6 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-7 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-9 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 60505-2866-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-8 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-6 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-7 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-9 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 60505-2866-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60505-2866-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60505-2866-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 60505-2866-3 | ed331223b511… | 672a5bd82f5f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079165-001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | |
| A079165-007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079165-001 | AB |
| A079165-002 | AB |
| A079165-003 | AB |
| A079165-004 | AB |
| A079165-005 | AB |
| A079165-006 | AB |
| A079165-007 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2012-02-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | 2012-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2012-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2012-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2012-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2012-02-07 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A079165-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079165-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079165-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079165-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079165-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079165-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079165-005 | AB | 1 | 03ed91905a0d… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ropinirole | ROPINIROLE | Marlex Pharmaceuticals Inc | 35d90f6f-3116-4afa-be2d-b65c160e8ab3 | 2025-11-21 | Warnings, Adverse reactions | 079165 ANDA079165 |