QuilliChew ER
- Product NDC
- 24478-074
- 11-digit product format
- 244780074
- Labeler code
- 24478
- Product ID
- 24478-074_4aab4051-898f-4a8b-8450-cabadf465f24
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate hydrochloride
- Dosage form
- TABLET, CHEWABLE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NextWave Pharmaceuticals, Inc
- Application
- NDA207960
- Marketing category
- NDA
- Marketing start
- 2016-04-18
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 20 mg/1
- 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
- QuilliChew ER
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1727443, 1727450, 1734928, 1734930, 1734951, 1734953 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24478-074-01 | QuilliChew ER | 100 in 1 BOTTLE | TABLET, CHEWABLE, EXTENDED RELEA | 100 | | 29 |
| 24478-074-02 | QuilliChew ER | 30 in 1 BOTTLE | TABLET, CHEWABLE, EXTENDED RELEA | 30 | | 29 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24478-074 | QUILLICHEW ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, CHEWABLE, EXTENDED RELEASE [NEXTWAVE PHARMACEUTICALS, INC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20231108_defc1205-8e90-4b1e-b862-05e4c35c7364.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24478-074-01 | 24478007401 | 100 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-01) | 2016-04-18 | 0000-00-00 | No | No | Current |
| 24478-074-02 | 24478007402 | 30 TABLET, CHEWABLE, EXTENDED RELEASE in 1 BOTTLE (24478-074-02) | 2026-05-01 | | No | No | Historical |