Methylphenidate Hydrochloride
- Product NDC
- 60687-554
- 11-digit product format
- 606870554
- Labeler code
- 60687
- Product ID
- 60687-554_4522b794-5c43-44cd-e063-6394a90ab39a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA211009
- Marketing category
- ANDA
- Marketing start
- 2020-06-25
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 36 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
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 36 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091155, 1091170, 1091185, 1091210 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-554-11 | Methylphenidate Hydrochloride | 1 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 1 | | 6 |
| 60687-554-21 | Methylphenidate Hydrochloride | 30 in 1 BOX, UNIT-DOSE | TABLET, EXTENDED RELEASE | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60687-554 | METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240922_f6581305-cd1e-4171-8c1b-e184c7bde033.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 |
|---|
| 60687-554-11 | 60687055411 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 60687-554-21 | 60687055421 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-554-21) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (60687-554-11) | 30 blister pack | 2020-06-25 | 0000-00-00 | No | No | Current |