Methylphenidate Hydrochloride
- Product NDC
- 55466-101
- 11-digit product format
- 554660101
- Labeler code
- 55466
- Product ID
- 55466-101_2df3eacd-fa7d-ac18-e063-6294a90a70b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Neolpharma, Inc.
- Application
- ANDA208737
- Marketing category
- ANDA
- Marketing start
- 2024-03-29
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 5 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091150, 1091392, 1091497 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55466-101-12 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 18 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55466-101 | METHYLPHENIDATE HYDROCHLORIDE TABLET [NEOLPHARMA, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250215_81141f59-21ca-c8b0-e053-2a91aa0a4c56.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 |
|---|
| 55466-101-12 | 55466010112 | 100 TABLET in 1 BOTTLE (55466-101-12) | 100 tablet | 2024-03-29 | 0000-00-00 | No | No | Current |