METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
- Product NDC
- 10702-075
- 11-digit product format
- 107020075
- Labeler code
- 10702
- Product ID
- 10702-075_40950048-0e42-4661-e063-6394a90a2bb1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate hydrochloride extended release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA207488
- Marketing category
- ANDA
- Marketing start
- 2015-06-09
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 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
- METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091145, 1091225 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10702-075-01 | 2024-02-16 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-01 | 2024-02-16 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-06 | 2024-02-16 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-06 | 2024-02-16 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 10702-075-06 | 2024-01-30 | C162847 | 48780-1 | 1030e365-473e-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Methylphenidate Hydrochloride Extended-Release Tablets USP CII safely and effectively. See full prescribing information for Methylphenidate Hydrochloride Extended-Release Tablets USP CII. Methylphenidate hydrochloride extended-release tablets, for oral use, CII Initial U.S. Approval: 1955 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10702-075-01 | METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE | 100 in 1 BOTTLE | TABLET | 100 | | 14 |
| 10702-075-06 | METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE | 60 in 1 BOTTLE | TABLET | 60 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10702-075 | METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240621_be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10702-075-01 | 10702007501 | 100 TABLET in 1 BOTTLE (10702-075-01) | 100 tablet | 2015-06-09 | 0000-00-00 | No | No | Current |
| 10702-075-06 | 10702007506 | 60 TABLET in 1 BOTTLE (10702-075-06) | 60 tablet | 2015-06-09 | 0000-00-00 | No | No | Current |