Dexmethylphenidate hydrochloride
- Product NDC
- 0115-1709
- 11-digit product format
- 001151709
- Labeler code
- 0115
- Product ID
- 0115-1709_b9254c68-2d68-4a6d-874b-d85a32ce4893
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA203614
- Marketing category
- ANDA
- Marketing start
- 2017-07-05
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 25 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexmethylphenidate hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1678OK0E08 |
| Rxcui | 1101926, 1101932 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0115-1709-01 | 2020-12-29 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-12-29 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
| 0115-1709-01 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-3578-f274-e053-dbdaa90a6471 | These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. DEXMETHYLPHENIDATE HYDROCHLORIDE extended-release capsules, for oral use, CII Initial U.S. Approval: 2005 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1709-01 | Dexmethylphenidate hydrochloride | 100 in 1 BOTTLE, PLASTIC | CAPSULE, EXTENDED RELEASE | 100 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1709 | DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 21 | Current NDC, Legacy NDC, 1 package rows | 20240919_be7019d7-eb3e-48eb-b6ba-0ffefae6dcd0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1709-01 | 00115170901 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1709-01) | 2017-07-05 | 0000-00-00 | No | No | Current |