Methylphenidate Hydrochloride
- Product NDC
- 0115-1741
- Requested package NDC
- 0115-1741-01
- 11-digit product format
- 001151741
- Labeler code
- 0115
- Product ID
- 0115-1741_a1946373-6df9-4fd8-8c10-3d8d8b6ad9ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA205105
- Marketing category
- ANDA
- Marketing start
- 2016-09-20
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 0115-1741 | 0115-1741-01 | Y | Unknown FDA exclusion code: Y | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205105-001 | AB2 |
| A205105-002 | AB2 |
| A205105-003 | AB2 |
| A205105-004 | AB2 |
| A205105-005 | AB2 |
| A205105-006 | AB2 |
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 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205105-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-005 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-006 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-006 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-005 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-006 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-004 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-005 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-006 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-004 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-005 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-006 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-003 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-004 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-005 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-006 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-004 | AB2 | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | 60 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4B3SC438HI | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 10aa0dc0-bd0e-4927-a19a-8722d78ad67d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0115-1741-01 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0115-1741-01 | EA - Each | 0115-1741 | 40a693a2-be89-41eb-8052-192035b377fc | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 10aa0dc0-bd0e-4927-a19a-8722d78ad67d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 205105 ANDA205105 0115-1741-01 0115-1741 00115174101 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0115-1741-01 | 00115174101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1741-01) | 2016-09-20 | 0000-00-00 | No | No | Current |