Focalin
- Product NDC
- 0078-0382
- 11-digit product format
- 000780382
- Labeler code
- 0078
- Product ID
- 0078-0382_ffb90063-7d7a-4f9e-ace8-19aebacf2e20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmethylphenidate hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA021278
- Marketing category
- NDA
- Marketing start
- 2001-11-30
- Marketing end
- 2026-07-31
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Focalin
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 1678OK0E08 |
| Rxcui | 899518, 899519, 899548, 899549, 899557, 899559 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ff349b0-f325-4585-9c0d-7dc58eb1bc1b | Product name | 1 | 20210818 |
| 7d5b6b15-5a1e-e1e5-992d-90d0701572ad | Product name | 9 | 20210511 |
| ccfbb2ac-2915-4b21-1d79-8a93f773e70f | Product name | 9 | 20200714 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0078-0382-05 | Focalin | 100 in 1 BOTTLE | TABLET | 100 | 28 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0078-0382-05 | EA - Each | 0078-0382 | e85a43fc-1280-4a64-81c7-4f7bcef6dcb3 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 899548 | dexmethylphenidate HCl 10 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899557 | dexmethylphenidate HCl 2.5 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899518 | dexmethylphenidate HCl 5 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899549 | Focalin 10 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899559 | Focalin 2.5 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899519 | Focalin 5 MG Oral Tablet | PSN | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899549 | dexmethylphenidate hydrochloride 10 MG Oral Tablet [Focalin] | SBD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899559 | dexmethylphenidate hydrochloride 2.5 MG Oral Tablet [Focalin] | SBD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899519 | dexmethylphenidate hydrochloride 5 MG Oral Tablet [Focalin] | SBD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899548 | dexmethylphenidate hydrochloride 10 MG Oral Tablet | SCD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899557 | dexmethylphenidate hydrochloride 2.5 MG Oral Tablet | SCD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899518 | dexmethylphenidate hydrochloride 5 MG Oral Tablet | SCD | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899549 | Focalin (dexmethylphenidate hydrochloride 10 MG) Oral Tablet | SY | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899559 | Focalin (dexmethylphenidate hydrochloride 2.5 MG) Oral Tablet | SY | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899549 | Focalin 10 MG Oral Tablet | SY | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899559 | Focalin 2.5 MG Oral Tablet | SY | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
| 899519 | Focalin 5 MG Oral Tablet | SY | 7c552f11-e24a-4d9b-bb8d-be10c928eca8 | 28 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0078-0382-05 | 00078038205 | 100 TABLET in 1 BOTTLE (0078-0382-05) | 100 tablet | 2001-11-30 | 0000-00-00 | No | No | Current |