Dexmethylphenidate Hydrochloride
- Product NDC
- 0781-2684
- 11-digit product format
- 007812684
- Labeler code
- 0781
- Product ID
- 0781-2684_f2976909-5df3-4d53-b2f9-e49a840b4cf7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sandoz Inc
- Application
- NDA021802
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2014-01-28
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | ACTIVE INGREDIENT | 1678OK0E08 | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| DEXMETHYLPHENIDATE | ACTIVE MOIETY | M32RH9MFGP | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE A | INACTIVE INGREDIENT | 8GQS4E66YY | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-2684 | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC] | 15 | Legacy NDC | 20200624_77342716-6dd7-488d-bfa4-9637feb4b5f0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-2684-01 | 00781268401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0781-2684-01) | 2014-01-28 | 0000-00-00 | No | No | Current |