Application 211009
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 18MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 27MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 36MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 54MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | |
| A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | |
| A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | |
| A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211009-001 | AB |
| A211009-002 | AB |
| A211009-003 | AB |
| A211009-004 | 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 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-001 | METHYLPHENIDATE HYDROCHLORIDE | 18MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-002 | METHYLPHENIDATE HYDROCHLORIDE | 27MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-003 | METHYLPHENIDATE HYDROCHLORIDE | 36MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-004 | METHYLPHENIDATE HYDROCHLORIDE | 54MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2019-09-03 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211009-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211009-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211009-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211009-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211009-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211009-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211009-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211009-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211009-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211009-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211009-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211009-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211009-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211009-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211009-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211009-004 | AB | 1 | 5bbf6a4d5a75… |
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 | f6581305-cd1e-4171-8c1b-e184c7bde033 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 211009 ANDA211009 60687-543 60687-532 60687-554 60687-565 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | b9af3104-172d-4975-9301-b9fe7db9ef12 | 2021-08-17 | Boxed warning, Warnings, Adverse reactions | 211009 ANDA211009 31722-952 31722-955 31722-953 31722-954 |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc. | b07150db-fd99-4400-bb83-b3a7544a917a | 2021-08-17 | Boxed warning, Warnings, Adverse reactions | 211009 ANDA211009 72865-133 72865-136 72865-134 72865-135 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-124 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-124 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-125 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-125 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-126 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-126 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-127 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 16714-127 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Northstar Rx LLC | ANDA | Current |
| 31722-952 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-952 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-953 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-953 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-954 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-954 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals Inc | ANDA | Current |
| 31722-955 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-955 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Camber Pharmaceuticals Inc | ANDA | Current |
| 50268-545 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-545 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-546 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-546 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-547 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-547 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-548 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 50268-548 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | AvPAK | ANDA | Current |
| 60687-532 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-532 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-532 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-543 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-543 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-543 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-554 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-554 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-554 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-565 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-565 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-565 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | American Health Packaging | ANDA | Current |
| 63629-1231 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1231 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1231 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1902 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1902 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1902 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1903 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1903 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1903 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1904 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1904 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-1904 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72865-133 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals Inc | ANDA | Current |
| 72865-133 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals, Inc. | ANDA | Current |
| 72865-134 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals Inc | ANDA | Current |
| 72865-134 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals, Inc. | ANDA | Current |
| 72865-135 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals Inc | ANDA | Current |
| 72865-135 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals, Inc. | ANDA | Current |
| 72865-136 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals Inc | ANDA | Current |
| 72865-136 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | XLCare Pharmaceuticals, Inc. | ANDA | Current |