Methylphenidate Hydrochloride
- Product NDC
- 50268-546
- 11-digit product format
- 502680546
- Labeler code
- 50268
- Product ID
- 50268-546_47e731b7-b64e-317b-e063-6294a90a2c8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA211009
- Marketing category
- ANDA
- Marketing start
- 2021-04-22
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 27 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 | 27 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091155, 1091170, 1091185, 1091210 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-546-11 | Methylphenidate Hydrochloride | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 4 |
| 50268-546-12 | Methylphenidate Hydrochloride | 20 in 1 BOX | TABLET, EXTENDED RELEASE | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-546 | METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AVPAK] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240110_c0906610-294d-1320-e053-2995a90ad8fd.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 |
|---|
| 50268-546-11 | 50268054611 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-546-12 | 50268054612 | 20 BLISTER PACK in 1 BOX (50268-546-12) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (50268-546-11) | 20 blister pack | 2021-04-22 | 0000-00-00 | No | No | Current |