Methylphenidate Hydrochloride
- Product NDC
- 13811-710
- 11-digit product format
- 138110710
- Labeler code
- 13811
- Product ID
- 13811-710_0944cf70-d59a-483b-9698-e96ef955a65a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Trigen Laboratories, LLC
- Application
- ANDA205327
- Marketing category
- ANDA
- Marketing start
- 2017-12-29
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 72 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 72 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091155, 1091170, 1091185, 1091210, 1995461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13811-710-10 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 54 |
| 13811-710-30 | Methylphenidate Hydrochloride | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 54 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13811-710 | METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC] | 49 | Current NDC, Legacy NDC, 2 package rows | 20240906_c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f.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 |
|---|
| 13811-710-10 | 13811071010 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-710-10) | 2017-12-29 | 2027-04-30 | No | No | Current |
| 13811-710-30 | 13811071030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-710-30) | 2017-12-29 | 0000-00-00 | No | No | Current |