Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 70010-015
Methylphenidate hydrochloride 40 mg/1 · Capsule, Extended release · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-015-01 | 7001000150170010001501 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-015-01)Marketed from Sep 10, 2019 |
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)
- Methylphenidate Hydrochloride
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 40 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 211796
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 70010-015_5d4e3a29-ca13-9c98-e063-6294a90a682dSPL ID 5d4e3a29-ca13-9c98-e063-6294a90a682d
- 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
N470010001501followed by a unit qualifier and the quantityPackage 70010-0015-01. 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 70010-015
- What is NDC 70010-015?
- 70010-015 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 40 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?
- Methylphenidate Hydrochloride.
- What is the active ingredient?
- Methylphenidate 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 Methylphenidate Hydrochloride?
- 148 other product NDCs are listed under this name. See all Methylphenidate Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methylphenidate 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) |
|---|---|---|---|---|---|
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Northstar Rx LLC | 72603-399 | 72603-0399-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-710 | 57664-0710-8357664-0710-88 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2968 | 71335-2968-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2428 | 72162-2428-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2429 | 72162-2429-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2430 | 72162-2430-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-324 | 75834-0324-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-325 | 75834-0325-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-326 | 75834-0326-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 63 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-700 | 13811-0700-30 |
Other NDCs under ANDA 211796
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 |
|---|---|---|---|---|
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-012 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-013 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-014 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-016 |