METHYLPHENIDATE HYDROCHLORIDE
- Product NDC
- 63629-3279
- 11-digit product format
- 636293279
- Labeler code
- 63629
- Product ID
- 63629-3279_3d40a0bf-21c0-423b-bff8-e8b719345b9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHYLPHENIDATE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- bryant ranch prepack
- Application
- ANDA040300
- Marketing category
- ANDA
- Marketing start
- 2010-02-01
- Marketing end
- 0000-00-00
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63629-3279-1 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d022-8e05-e053-dbdaa90a074a | methylphenidate hydrochloride 10mg Tablet |
| 63629-3279-2 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d022-8e05-e053-dbdaa90a074a | methylphenidate hydrochloride 10mg Tablet |
| 63629-3279-3 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d022-8e05-e053-dbdaa90a074a | methylphenidate hydrochloride 10mg Tablet |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-3279-1 | METHYLPHENIDATE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 63629-3279-2 | METHYLPHENIDATE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 63629-3279-3 | METHYLPHENIDATE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-3279-1 | EA - Each | 63629-3279 | d8ddf969-08c4-4b4b-8afd-82d05c949462 | 1 | 2015-10-02 |
| 63629-3279-2 | EA - Each | 63629-3279 | 640fb871-d267-4711-b859-a69acce78260 | 1 | 2015-10-02 |
| 63629-3279-3 | EA - Each | 63629-3279 | a89975df-0b63-4f1d-a141-efeb9173a2ab | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE | ACTIVE INGREDIENT | 4B3SC438HI | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | |
| METHYLPHENIDATE | ACTIVE MOIETY | 207ZZ9QZ49 | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-3279 | METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 1 | Legacy NDC, 3 package rows | 20101012_0fcdbdb5-4b27-4ef8-aa1c-b72d355def41.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091150 | methylphenidate HCl 10 MG Oral Tablet | PSN | 0fcdbdb5-4b27-4ef8-aa1c-b72d355def41 | 1 |
| 1091150 | methylphenidate hydrochloride 10 MG Oral Tablet | SCD | 0fcdbdb5-4b27-4ef8-aa1c-b72d355def41 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 63629-3279-1 | 63629327901 | 30 in 1 BOTTLE | Historical |
| 63629-3279-2 | 63629327902 | 90 in 1 BOTTLE | Historical |
| 63629-3279-3 | 63629327903 | 60 in 1 BOTTLE | Historical |