0078-0608 : 24 Hr Focalin 25 mg Extended Release Capsule
| NDC: | 0078-0608 |
| Labeler: | Novartis Pharmaceuticals Corporation |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Focalin XR |
| Dosage Form: | Oral Capsule, Extended Release |
| Application #: | NDA021802 |
| Rev. Date: | |
| CSA Schedule: | CII (US) [1] |
[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.
Appearance:
| Markings: | NVR;D25 |
| Shapes: |
Capsule |
| Colors: |
 Blue |
| Size (mm): | 19 |
| Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. | |
NDC Package Codes:
- 0078-0608-05: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0078‑0608‑05)
Active Ingredients:
- Dexmethylphenidate Hydrochloride
Dosage Strength:
- 25 mg
Inactive Ingredients:
- Gelatin
- Polyethylene Glycols
- Dextrose
- Talc
- Titanium Dioxide
- Triethyl Citrate
- Fd&c Blue No. 2
Pharmaceutical Classes:
- Central Nervous System Stimulant [EPC]
- Central Nervous System Stimulation [PE]
Related Products:
Based on records with the same trade name.- 0078-0380 Focalin 2.5 mg Oral Tablet by Novartis Pharmaceuticals Corporation
- 0078-0381 Focalin 5 mg Oral Tablet by Novartis Pharmaceuticals Corporation
- 0078-0382 Focalin 10 mg Oral Tablet by Novartis Pharmaceuticals Corporation
- 0078-0430 Focalin XR 5 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0431 24 Hr Focalin 10 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0432 Focalin XR 20 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0433 Focalin XR 30 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0434 24 Hr Focalin 40 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0493 Focalin XR 15 mg 24 Hr Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 0078-0609 24 Hr Focalin 35 mg Extended Release Capsule by Novartis Pharmaceuticals Corporation
- 16590-649 Focalin XR 15 mg 24 Hr Extended Release Capsule by Stat Rx USA LLC
NDC QR Code
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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.