METHYLPHENIDATE HYDROCHLORIDE
- Product NDC
- 70010-043
- 11-digit product format
- 700100043
- Labeler code
- 70010
- Product ID
- 70010-043_4d32fc20-a85a-ae84-e063-6294a90ade10
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLPHENIDATE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Granules Pharmaceuticals Inc.
- Application
- ANDA210992
- Marketing category
- ANDA
- Marketing start
- 2018-12-17
- 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
- METHYLPHENIDATE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091145, 1091225 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70010-043-01 | METHYLPHENIDATE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | 10 | |
| 70010-043-03 | METHYLPHENIDATE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70010-043-01 | EA - Each | 70010-043 | b2420b82-7599-4679-8570-862ffb879765 | 1 | 2019-07-02 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091145 | methylphenidate HCl 10 MG 8HR Extended Release Oral Tablet | PSN | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
| 1091225 | methylphenidate HCl 20 MG 8HR Extended Release Oral Tablet | PSN | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
| 1091145 | 8 HR methylphenidate hydrochloride 10 MG Extended Release Oral Tablet | SCD | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
| 1091225 | 8 HR methylphenidate hydrochloride 20 MG Extended Release Oral Tablet | SCD | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
| 1091145 | methylphenidate HCl 10 MG 8 HR Extended Release Oral Tablet | SY | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
| 1091225 | methylphenidate HCl 20 MG 8 HR Extended Release Oral Tablet | SY | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70010-043-01 | 70010004301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-01) | 2018-12-17 | 0000-00-00 | No | No | Current |
| 70010-043-03 | 70010004303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70010-043-03) | 2022-10-31 | No | No | Historical |