Methylphenidate Hydrochloride
- Product NDC
- 63629-1921
- 11-digit product format
- 636291921
- Labeler code
- 63629
- Product ID
- 63629-1921_6c139623-fa63-4d58-8e4b-b7538e09b3c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA210354
- Marketing category
- ANDA
- Marketing start
- 2018-03-01
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091389 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1921-1 | 63629192101 | 100 TABLET, CHEWABLE in 1 BOTTLE (63629-1921-1) | 2021-12-21 | 0000-00-00 | No | No | Current |