Dexmethylphenidate Hydrochloride
- Product NDC
- 43386-862
- 11-digit product format
- 433860862
- Labeler code
- 43386
- Product ID
- 43386-862_4d2d72fd-412e-4556-9adc-d4673576a29c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA204534
- Marketing category
- ANDA
- Marketing start
- 2015-12-04
- Substance
- DEXMETHYLPHENIDATE 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
- Dexmethylphenidate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1678OK0E08 |
| Rxcui | 899518, 899548, 899557 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-862-01 | Dexmethylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 43386-862-03 | Dexmethylphenidate Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 43386-862-10 | Dexmethylphenidate Hydrochloride | 1000 in 1 BOTTLE | TABLET | 1000 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-862 | DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20240131_a61932ef-c2b6-4363-a21d-1f0358f317b6.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 |
|---|
| 43386-862-01 | 43386086201 | 100 TABLET in 1 BOTTLE (43386-862-01) | 100 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |
| 43386-862-03 | 43386086203 | 30 TABLET in 1 BOTTLE (43386-862-03) | 30 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |
| 43386-862-10 | 43386086210 | 1000 TABLET in 1 BOTTLE (43386-862-10) | 1000 tablet | 2015-12-04 | 0000-00-00 | No | No | Current |