Methylphenidate Hydrochloride
- Product NDC
- 67877-618
- 11-digit product format
- 678770618
- Labeler code
- 67877
- Product ID
- 67877-618_c6ff917f-4793-4098-b8b8-e1b31f10677b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA211779
- Marketing category
- ANDA
- Marketing start
- 2019-10-06
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091150, 1091392, 1091497 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 67877-618-01 | 2022-09-07 | C162847 | 48780-1 | e4f33bdf-b1d4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 67877-618-33 | 2022-09-07 | C162847 | 48780-1 | e4f33bdf-b1d4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 67877-618-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b1d4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1955 |
| 67877-618-33 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-b1d4-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. METHYLPHENIDATE HYDROCHLORIDE 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 |
|---|
| 67877-618-01 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 67877-618-33 | Methylphenidate Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 9 |
| 67877-618-33 | Methylphenidate Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67877-618 | METHYLPHENIDATE HYDROCHLORIDE TABLET [ASCEND LABORATORIES, LLC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240716_8e97c9f3-956c-416a-a7c2-68bb92053ce5.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 |
|---|
| 67877-618-01 | 67877061801 | 100 TABLET in 1 BOTTLE (67877-618-01) | 100 tablet | 2019-10-06 | 0000-00-00 | No | No | Current |
| 67877-618-33 | 67877061833 | 10 BLISTER PACK in 1 CARTON (67877-618-33) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2019-10-06 | 0000-00-00 | No | No | Current |