DEXMETHYLPHENIDATE HYDROCHLORIDE
- Product NDC
- 43602-331
- 11-digit product format
- 436020331
- Labeler code
- 43602
- Product ID
- 43602-331_47833074-8691-4e8b-9f72-7bb4efda36a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Ascent Pharmaceuticals, Inc.
- Application
- ANDA215523
- Marketing category
- ANDA
- Marketing start
- 2021-12-08
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43602-331 | DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ASCENT PHARMACEUTICALS, INC.] | 3 | Legacy NDC | 20211216_7b7e5069-6c58-4093-bb19-37d52fe67fd6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43602-331-05 | 43602033105 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-331-05) | 2021-12-08 | 0000-00-00 | No | No | Current |
| 43602-331-30 | 43602033130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43602-331-30) | 2021-12-08 | 0000-00-00 | No | No | Current |