Methylphenidate Hydrochloride
- Product NDC
- 0527-3310
- 11-digit product format
- 005273310
- Labeler code
- 0527
- Product ID
- 0527-3310_b80118d9-003b-41b9-b156-e10cfb84712d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA211918
- Marketing category
- ANDA
- Marketing start
- 2019-04-24
- Marketing end
- 0000-00-00
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 18 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methylphenidate Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | 18 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091155, 1091170, 1091185, 1091210 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0527-3310-37 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-3310-37 | EA - Each | 0527-3310 | aa3157f4-1a3b-4e19-b47a-1d885d68c62b | 1 | 2019-06-19 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091155 | methylphenidate HCl 18 MG 24HR Extended Release Oral Tablet | PSN | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091170 | methylphenidate HCl 27 MG 24HR Extended Release Oral Tablet | PSN | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091185 | methylphenidate HCl 36 MG 24HR Extended Release Oral Tablet | PSN | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091210 | methylphenidate HCl 54 MG 24HR Extended Release Oral Tablet | PSN | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091155 | 24 HR methylphenidate hydrochloride 18 MG Extended Release Oral Tablet | SCD | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091170 | 24 HR methylphenidate hydrochloride 27 MG Extended Release Oral Tablet | SCD | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091185 | 24 HR methylphenidate hydrochloride 36 MG Extended Release Oral Tablet | SCD | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091210 | 24 HR methylphenidate hydrochloride 54 MG Extended Release Oral Tablet | SCD | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091155 | methylphenidate hydrochloride 18 MG 24 HR Extended Release Oral Tablet | SY | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091170 | methylphenidate hydrochloride 27 MG 24 HR Extended Release Oral Tablet | SY | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091185 | methylphenidate hydrochloride 36 MG 24 HR Extended Release Oral Tablet | SY | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
| 1091210 | methylphenidate hydrochloride 54 MG 24 HR Extended Release Oral Tablet | SY | 44737c1d-fe75-409e-8a58-591696d3d7aa | 13 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0527-3310-37 | 00527331037 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0527-3310-37) | 2019-04-24 | 0000-00-00 | No | No | Current |