Dexmethylphenidate Hydrochloride
- Product NDC
- 63629-2307
- 11-digit product format
- 636292307
- Labeler code
- 63629
- Product ID
- 63629-2307_e3e20e09-b76f-487f-802e-dd26ccdd753d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmethylphenidate hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207901
- Marketing category
- ANDA
- Marketing start
- 2001-11-30
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 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
- Dexmethylphenidate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1678OK0E08 |
| Rxcui | 899548 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-2307-1 | Dexmethylphenidate Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-2307 | DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20240112_f88da72d-c22f-413b-9dce-60871299b06a.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 |
|---|
| 63629-2307-1 | 63629230701 | 100 TABLET in 1 BOTTLE, PLASTIC (63629-2307-1) | 100 tablet | 2021-12-22 | 0000-00-00 | No | No | Current |