Pramipexole Dihydrochloride
- Product NDC
- 68382-476
- 11-digit product format
- 683820476
- Labeler code
- 68382
- Product ID
- 68382-476_4c93c76b-c6af-4d4c-b8b6-c5bc60829ae5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pramipexole Dihydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202891
- Marketing category
- ANDA
- Marketing start
- 2018-04-24
- Marketing end
- 0000-00-00
- Substance
- PRAMIPEXOLE DIHYDROCHLORIDE
- Active strength
- 2 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68382-476 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 68382-476 | 68382-476-06 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68382-476 | 68382-476-77 | D | Discontinued by firm | 2026-09-14 |
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 | 68382-476-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68382-476-77 | 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 | 68382-476-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68382-476-77 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | |
| A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202891-001 | AB |
| A202891-002 | AB |
| A202891-003 | AB |
| A202891-004 | AB |
| A202891-005 | AB |
| A202891-006 | AB |
| A202891-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-006 | PRAMIPEXOLE DIHYDROCHLORIDE | 3.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-007 | PRAMIPEXOLE DIHYDROCHLORIDE | 4.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-001 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.375MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-002 | PRAMIPEXOLE DIHYDROCHLORIDE | 0.75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-003 | PRAMIPEXOLE DIHYDROCHLORIDE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-004 | PRAMIPEXOLE DIHYDROCHLORIDE | 2.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-005 | PRAMIPEXOLE DIHYDROCHLORIDE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-12 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202891-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A202891-007 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A202891-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202891-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202891-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202891-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202891-005 | AB | 1 | fd3edfee7708… |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-476-06 | 68382047606 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-476-06) | 2018-04-24 | 0000-00-00 | No | No | Current | |
| 68382-476-77 | 68382047677 | 10 BLISTER PACK in 1 CARTON (68382-476-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-476-30) | 10 blister pack | 2018-04-24 | 0000-00-00 | No | No | Current |