ropinirole hydrochloride
- Product NDC
- 63629-4641
- Requested package NDC
- 63629-4641-1
- 11-digit product format
- 636294641
- Labeler code
- 63629
- Product ID
- 63629-4641_db4a14bc-da4c-40aa-9596-ffb1d293e4c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ropinirole hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA078110
- Marketing category
- ANDA
- Marketing start
- 2011-09-20
- Marketing end
- 0000-00-00
- Substance
- ROPINIROLE HYDROCHLORIDE
- Active strength
- 5 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#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63629-4641 | 63629-4641-1 | I | Inactivated by FDA | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078110-001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | RS | 2008-05-05 |
| A078110-002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2008-05-05 | |
| A078110-003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2008-05-05 | |
| A078110-004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2008-05-05 | |
| A078110-005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2008-05-05 | |
| A078110-006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2008-05-05 | |
| A078110-007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2008-07-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078110-001 | AB |
| A078110-002 | AB |
| A078110-003 | AB |
| A078110-004 | AB |
| A078110-005 | AB |
| A078110-006 | AB |
| A078110-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A078110-001 | ROPINIROLE HYDROCHLORIDE | EQ 0.25MG BASE | TABLET / ORAL | AB | RS | 2008-05-05 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-002 | ROPINIROLE HYDROCHLORIDE | EQ 0.5MG BASE | TABLET / ORAL | AB | 2008-05-05 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078110-003 | ROPINIROLE HYDROCHLORIDE | EQ 1MG BASE | TABLET / ORAL | AB | 2008-05-05 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078110-004 | ROPINIROLE HYDROCHLORIDE | EQ 2MG BASE | TABLET / ORAL | AB | 2008-05-05 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078110-005 | ROPINIROLE HYDROCHLORIDE | EQ 3MG BASE | TABLET / ORAL | AB | 2008-05-05 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078110-006 | ROPINIROLE HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2008-05-05 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A078110-007 | ROPINIROLE HYDROCHLORIDE | EQ 5MG BASE | TABLET / ORAL | AB | 2008-07-11 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A078110-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-005 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-006 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A078110-007 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | A-S Medication Solutions | a97d5e2d-4a17-4d80-9216-1b0780199502 | 2026-03-23 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | Northwind Health Company, LLC | ab6d21b6-2584-4b97-e053-2a95a90adc50 | 2026-01-01 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | SOLCO HEALTHCARE US, LLC | 7734ef0b-584f-42dd-a8b5-adbdf4e4df93 | 2025-05-30 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | SOLCO HEALTHCARE US, LLC | 5823b3a2-3256-4d94-97b4-ec6b940312f4 | 2025-05-28 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | AvPAK | e699a31a-25fc-554b-e053-2a95a90a843a | 2025-01-09 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | American Health Packaging | 6849b3c0-e36b-4bea-82f2-b33ae3d44c95 | 2025-01-08 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | Bryant Ranch Prepack | 6c10444a-48da-469d-bf8f-1e6e0b7e15f8 | 2023-10-30 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | Proficient Rx LP | 89e3865c-1fe1-4f29-9606-8830df4bbe53 | 2023-08-01 | Warnings, Adverse reactions | 078110 ANDA078110 |
| ropinirole hydrochloride | ROPINIROLE HYDROCHLORIDE | A-S Medication Solutions | 9c4dacc6-cebc-4f42-85fc-41083512b290 | 2023-03-01 | Warnings, Adverse reactions | 078110 ANDA078110 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dc920868-8845-b908-7ca8-0dee3e345af5 | Product name | 2 | 20230123 |
| e24bc1b4-1e16-908e-3d09-29da3ca2fb1f | Product name | 2 | 20170517 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-4641-1 | 2024-01-30 | C162847 | 48780-1 | 9d75b9cf-fe6c-f424-e053-dadaa90a57ce | These 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 Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-4641-1 | ropinirole hydrochloride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1006 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-4641-1 | EA - Each | 63629-4641 | 27a3ed06-5806-4adc-a40a-0d0e12c0d3c2 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-4641 | ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 1006 | Legacy NDC, 1 package rows | 20220505_ed314bc0-7ceb-441c-bf18-d24df66fbc5f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312849 | rOPINIRole HCl 5 MG Oral Tablet | PSN | ed314bc0-7ceb-441c-bf18-d24df66fbc5f | 1006 |
| 312849 | ropinirole 5 MG Oral Tablet | SCD | ed314bc0-7ceb-441c-bf18-d24df66fbc5f | 1006 |
| 312849 | ropinirole 5 MG (as ropinirole hydrochloride) Oral Tablet | SY | ed314bc0-7ceb-441c-bf18-d24df66fbc5f | 1006 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-4641-1 | 63629464101 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-4641-1) | 2011-12-05 | 0000-00-00 | No | No | Current |