Methylphenidate Hydrochloride
- Product NDC
- 57664-710
- 11-digit product format
- 576640710
- Labeler code
- 57664
- Product ID
- 57664-710_50366898-d881-7c3b-e063-6294a90a8de8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA217229
- Marketing category
- ANDA
- Marketing start
- 2024-12-20
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 72 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
- Methylphenidate Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 72 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1995461 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-710-83 | Methylphenidate Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 2 |
| 57664-710-88 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-710 | METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 1 | Current NDC, 2 package rows | 20241222_18024571-4505-6d51-e063-6294a90a1972.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 57664-710-83 | 57664071083 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-710-83) | 2024-12-20 | No | No | Current |
| 57664-710-88 | 57664071088 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-710-88) | 2024-12-20 | No | No | Current |