Methylphenidate Hydrochloride
- Product NDC
- 0406-1146
- 11-digit product format
- 004061146
- Labeler code
- 0406
- Product ID
- 0406-1146_3c286d0f-d6c0-47f5-af8b-9a744477a11f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA040300
- Marketing category
- ANDA
- Marketing start
- 1998-11-27
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 20 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | |
| A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | |
| A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040300-001 | AB |
| A040300-002 | AB |
| A040300-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1998-11-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 1998-11-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040300-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 1998-11-27 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040300-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040300-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040300-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040300-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040300-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040300-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040300-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040300-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040300-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040300-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040300-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040300-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040300-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040300-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040300-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040300-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4B3SC438HI | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 981a2ad8-33f7-4678-9162-9df9685bd4a6 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-1146-01 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 44 | |
| 0406-1146-10 | Methylphenidate Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 44 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-1146-01 | EA - Each | 0406-1146 | 263576d1-81a0-4782-ac36-e9d418ca9909 | 1 | 2012-07-24 |
| 0406-1146-10 | EA - Each | 0406-1146 | 38523dd7-ec04-4dcf-9ff4-593431fafe50 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | American Health Packaging | eb9b7377-d918-43fb-8e82-d14c85ed64a8 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | 040300 ANDA040300 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 040300 ANDA040300 0406-1146 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091150 | methylphenidate HCl 10 MG Oral Tablet | PSN | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
| 1091392 | methylphenidate HCl 20 MG Oral Tablet | PSN | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
| 1091497 | methylphenidate HCl 5 MG Oral Tablet | PSN | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
| 1091150 | methylphenidate hydrochloride 10 MG Oral Tablet | SCD | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
| 1091392 | methylphenidate hydrochloride 20 MG Oral Tablet | SCD | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
| 1091497 | methylphenidate hydrochloride 5 MG Oral Tablet | SCD | 981a2ad8-33f7-4678-9162-9df9685bd4a6 | 44 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0406-1146-01 | 00406114601 | 100 TABLET in 1 BOTTLE (0406-1146-01) | 100 tablet | 1998-11-27 | 0000-00-00 | No | No | Current |
| 0406-1146-10 | 00406114610 | 1000 TABLET in 1 BOTTLE (0406-1146-10) | 1000 tablet | 1998-11-27 | 0000-00-00 | No | No | Current |