Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 13107-381
Methylphenidate hydrochloride 10 mg/1 · Tablet · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-381-01 | 13107038101 | 100 TABLET in 1 BOTTLE (13107-381-01)Marketed from Apr 11, 2017 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma, LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209276
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 13107-381_f9c3ae42-cf3d-48b8-8a16-c23e1f1ad319SPL ID f9c3ae42-cf3d-48b8-8a16-c23e1f1ad319SPL set ID 35be77db-fbe3-487e-a220-a08a11aaec28RxCUI 1091150, 1091392, 1091497UNII 4B3SC438HI
- 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
N413107038101followed by a unit qualifier and the quantityPackage 13107-0381-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Methylphenidate Hydrochloride Tablets is indicated for the treatment of: • Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults • Narcolepsy Methylphenidate Hydrochloride Tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Excerpt only. Read the full label for complete information.
About NDC 13107-381
- What is NDC 13107-381?
- 13107-381 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 10 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. 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?
- Aurolife Pharma, LLC, NDC labeler code 13107. 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 209276
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 20 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-382 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-380 |