Methylphenidate Hydrochloride
- Product NDC
- 72603-399
- 11-digit product format
- 726030399
- Labeler code
- 72603
- Product ID
- 72603-399_24936e25-28cd-53ce-e063-6294a90ad99d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA217229
- Marketing category
- ANDA
- Marketing start
- 2025-02-01
- 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
- 2026-12-31
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-399-01 | Methylphenidate Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-399 | METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [NORTHSTAR RX LLC] | 1 | Current NDC, 1 package rows | 20250201_768bf181-d0d8-49e5-9c87-cacbb069e0b2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-399-01 | 72603039901 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72603-399-01) | 2025-02-01 | No | No | Historical |