NDC 66758-235 – Focalin XR
Dexmethylphenidate Hydrochloride 5 mg/1 · Capsule, Extended Release · Oral
Product NDC66758-235
Product details
- Brand name
- Focalin XR
- Generic name
- Dexmethylphenidate hydrochloride
- Labeler
- Sandoz Inc
- Dosage form
- Capsule, Extended Release
- Route
- Oral
- Marketing category
- NDA · NDA021802
- Marketed since
- May 31, 2005
- Listing expires
- December 31, 2026
- Pharmacologic class
- Central Nervous System Stimulant
Active ingredients
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 66758-235-01 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-01) | Jan 15, 2025 |
| 66758-235-31 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (66758-235-31) | Nov 17, 2025 |
Recalls mentioning this NDC
- D-0608-2026 Jun 24, 2026 · Class III
Labeling: Incorrect or Missing Lot and/or Exp Date
Other Focalin products
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- 0078-0432 Dexmethylphenidate Hydrochloride 20 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0433 Dexmethylphenidate Hydrochloride 30 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0434 Dexmethylphenidate Hydrochloride 40 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0493 Dexmethylphenidate Hydrochloride 15 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0608 Dexmethylphenidate Hydrochloride 25 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0609 Dexmethylphenidate Hydrochloride 35 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 0078-0430 Dexmethylphenidate Hydrochloride 5 mg/1 · Capsule, Extended Release · Novartis Pharmaceuticals Corporation
- 66758-237 Dexmethylphenidate Hydrochloride 15 mg/1 · Capsule, Extended Release · Sandoz Inc
- 66758-242 Dexmethylphenidate Hydrochloride 40 mg/1 · Capsule, Extended Release · Sandoz Inc
- 66758-241 Dexmethylphenidate Hydrochloride 35 mg/1 · Capsule, Extended Release · Sandoz Inc
- 66758-240 Dexmethylphenidate Hydrochloride 30 mg/1 · Capsule, Extended Release · Sandoz Inc