Quillivant
- Product NDC
- 24478-321
- 11-digit product format
- 244780321
- Labeler code
- 24478
- Product ID
- 24478-321_471e97b5-a75c-4901-be57-f77ad6a7856f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate hydrochloride
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NextWave Pharmaceuticals, Inc
- Application
- NDA202100
- Marketing category
- NDA
- Marketing start
- 2012-10-01
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 300 mg/60mL
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quillivant
- Brand name suffix
- XR
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 300 mg/60mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24478-321-02 | QuillivantXR | 60 mL in 1 BOTTLE | SUSPENSION, EXTENDED RELEASE | 60 | | 20 |
| 24478-321-02 | QuillivantXR | 1 in 1 CARTON | SUSPENSION, EXTENDED RELEASE | 1 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24478-321 | QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) SUSPENSION, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20231027_c2dc2109-44a6-4797-b04e-18761dd9d45a.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 |
|---|
| 24478-321-02 | 24478032102 | 1 BOTTLE in 1 CARTON (24478-321-02) / 60 mL in 1 BOTTLE | 1 bottle | 2012-10-01 | 0000-00-00 | No | No | Current |