Methylphenidate Hydrochloride
- Product NDC
- 0093-5346
- 11-digit product format
- 000935346
- Labeler code
- 0093
- Product ID
- 0093-5346_663ba889-95b5-45c2-af06-c90459d30d6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA079031
- Marketing category
- ANDA
- Marketing start
- 2012-07-16
- 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
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 | 0093-5346 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 0093-5346 | 0093-5346-01 | D | Discontinued by firm | 2026-09-14 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 |
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 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079031-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-003 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-004 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-002 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-003 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-004 | AB1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-001 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-002 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-003 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-004 | AB1 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-002 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-003 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-004 | AB1 | 1 | ea99ee380514… |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0093-5346-01 | Methylphenidate Hydrochloride(LA) | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0093-5346-01 | EA - Each | 0093-5346 | c62ad8f1-760f-4bca-a8be-adcd6a078de2 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0093-5346 | METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] | 10 | Current NDC, Legacy NDC, 1 package rows | 20211119_034fb7cd-e183-475e-8beb-64fd88facc8f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1806177 | methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule | PSN | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806179 | methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule | PSN | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806183 | methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule | PSN | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806177 | 50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule | SCD | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806179 | 50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule | SCD | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806183 | 50/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule | SCD | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806177 | methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule | SY | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806179 | methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule | SY | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
| 1806183 | methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule | SY | 034fb7cd-e183-475e-8beb-64fd88facc8f | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0093-5346-01 | 00093534601 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01) | 2012-07-16 | 0000-00-00 | No | No | Current |