Dexmethylphenidate hydrochloride
- Product NDC
- 57664-628
- 11-digit product format
- 576640628
- Labeler code
- 57664
- Product ID
- 57664-628_dfada2f5-18f1-4d93-96ad-7cbca3e712e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA206734
- Marketing category
- ANDA
- Marketing start
- 2021-11-05
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- 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 | 57664-628 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 57664-628 | 57664-628-88 | D | Discontinued by firm | 2026-10-12 |
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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | 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 | 57664-628-88 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 57664-628-88 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | ||
| A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 |
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 | A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-006 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-007 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206734-008 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2021-11-05 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-004 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-005 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-006 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-007 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206734-008 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-004 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-005 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-006 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-007 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206734-008 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-004 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-006 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-007 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206734-008 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-004 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-006 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-007 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206734-008 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-004 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-006 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-007 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206734-008 | AB | 1 | 1e350fbaab3a… |
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 | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-628-88 | EA - Each | 57664-628 | 86070dc8-df73-4273-a221-d1f098903296 | 1 | 2022-02-07 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 57664-628-88 | 57664062888 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-628-88) | 2021-11-05 | 0000-00-00 | No | No | Current |