Prescription drug · ANDA
Dexmethylphenidate Hydrochloride NDC 70010-005
Dexmethylphenidate hydrochloride 10 mg/1 · Capsule, Extended release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-005-01 | 7001000050170010000501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-005-01)Marketed from Dec 1, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dexmethylphenidate Hydrochloride
- Generic name (nonproprietary)
- dexmethylphenidate hydrochloride
- Active ingredients
- Dexmethylphenidate hydrochloride — 10 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Granules Pharmaceuticals Inc.NDC labeler code 70010
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213813
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70010-005_5d4e3549-d093-0608-e063-6394a90aee16SPL ID 5d4e3549-d093-0608-e063-6394a90aee16
- Pharmacologic class
- Central Nervous System Stimulant
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470010000501followed by a unit qualifier and the quantityPackage 70010-0005-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70010-005
- What is NDC 70010-005?
- 70010-005 is the product NDC for Dexmethylphenidate Hydrochloride, Dexmethylphenidate hydrochloride 10 mg/1 capsule, extended release, listed with the FDA by Granules Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexmethylphenidate Hydrochloride.
- What is the active ingredient?
- Dexmethylphenidate hydrochloride.
- Who is the labeler?
- Granules Pharmaceuticals Inc., NDC labeler code 70010. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexmethylphenidate Hydrochloride?
- 72 other product NDCs are listed under this name. See all Dexmethylphenidate Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexmethylphenidate Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2426 | 72162-2426-0172162-2426-06 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2427 | 72162-2427-01 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-327 | 75834-0327-01 |
| Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-328 | 75834-0328-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-229 | 31722-0229-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-230 | 31722-0230-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-231 | 31722-0231-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-232 | 31722-0232-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-233 | 31722-0233-01 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-234 | 31722-0234-01 |
Other NDCs under ANDA 213813
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 5 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-004 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 15 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-006 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-007 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 25 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-008 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-009 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 35 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-010 |
| Dexmethylphenidate Hydrochloride | Dexmethylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-011 |