Methylphenidate Hydrochloride
- Product NDC
- 57664-230
- 11-digit product format
- 576640230
- Labeler code
- 57664
- Product ID
- 57664-230_2f1c1df8-491a-08c9-e063-6394a90a1d06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090710
- Marketing category
- ANDA
- Marketing start
- 2013-08-16
- 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 |
|---|---|---|---|---|---|---|---|
| A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | |
| A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | |
| A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090710-001 | AB |
| A090710-002 | AB |
| A090710-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-03-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2012-03-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090710-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2012-03-15 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090710-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090710-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090710-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090710-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090710-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090710-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090710-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090710-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090710-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090710-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090710-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090710-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090710-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090710-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090710-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090710-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090710-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090710-001 | AB | 1 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|
| 1a89b390-0cd5-45cb-9e70-20de44652c56 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57664-230-08 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 16 | |
| 57664-230-13 | Methylphenidate Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | 16 | |
| 57664-230-18 | Methylphenidate Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | 16 | |
| 57664-230-83 | Methylphenidate Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 16 | |
| 57664-230-88 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-230-88 | EA - Each | 57664-230 | 26ff9d7a-2858-440e-a9b3-c6921574b334 | 1 | 2013-06-04 |
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 | Bryant Ranch Prepack | 5a22dd9b-9b48-4c96-8b20-0d20131521dc | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 090710 ANDA090710 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 1c7d7e6c-4e96-4d18-8dca-203ef50766ec | 2025-03-17 | Boxed warning, Warnings, Adverse reactions | 090710 ANDA090710 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 2025-02-27 | Boxed warning, Warnings, Adverse reactions | 090710 ANDA090710 57664-230 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091150 | methylphenidate HCl 10 MG Oral Tablet | PSN | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
| 1091392 | methylphenidate HCl 20 MG Oral Tablet | PSN | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
| 1091497 | methylphenidate HCl 5 MG Oral Tablet | PSN | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
| 1091150 | methylphenidate hydrochloride 10 MG Oral Tablet | SCD | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
| 1091392 | methylphenidate hydrochloride 20 MG Oral Tablet | SCD | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
| 1091497 | methylphenidate hydrochloride 5 MG Oral Tablet | SCD | 1a89b390-0cd5-45cb-9e70-20de44652c56 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57664-230-08 | 57664023008 | 100 TABLET in 1 BOTTLE (57664-230-08) | 100 tablet | 2013-08-16 | 0000-00-00 | No | No | Current |
| 57664-230-13 | 57664023013 | 500 TABLET in 1 BOTTLE (57664-230-13) | 500 tablet | 2013-08-16 | 0000-00-00 | No | No | Current |
| 57664-230-18 | 57664023018 | 1000 TABLET in 1 BOTTLE (57664-230-18) | 1000 tablet | 2013-08-16 | 0000-00-00 | No | No | Current |
| 57664-230-83 | 57664023083 | 30 TABLET in 1 BOTTLE (57664-230-83) | 30 tablet | 2013-08-16 | 0000-00-00 | No | No | Current |
| 57664-230-88 | 57664023088 | 100 TABLET in 1 BOTTLE (57664-230-88) | 100 tablet | 2013-08-16 | 0000-00-00 | No | No | Current |