Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 72865-127
Methylphenidate hydrochloride 10 mg/1 · Tablet, Chewable · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-127-01 | 72865012701 | 100 TABLET, CHEWABLE in 1 BOTTLE (72865-127-01)Marketed from Mar 1, 2018 |
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, Chewable
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc.NDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210354
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 72865-127_96784c11-8f1f-4073-9691-1a1627c79a61SPL ID 96784c11-8f1f-4073-9691-1a1627c79a61SPL set ID 91833146-fa95-471a-8b8d-6d36a2db5c9aRxCUI 1091152, 1091322, 1091389UNII 4B3SC438HIUPC 0372865125014, 0372865127018, 0372865126011
- 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
N472865012701followed by a unit qualifier and the quantityPackage 72865-0127-01. 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)
INDICATIONS AND USAGE Attention Deficit Disorders, Narcolepsy Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distrac…
Excerpt only. Read the full label for complete information.
About NDC 72865-127
- What is NDC 72865-127?
- 72865-127 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 10 mg/1 tablet, chewable, listed with the FDA by XLCare 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?
- XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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?
- 149 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 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 20 mg/1 | TabletOral | Nivagen Pharmaceuticals, Inc. | 75834-326 | 75834-0326-01 |
| 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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2968 | 71335-2968-01 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 63 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-700 | 13811-0700-30 |
Other NDCs under ANDA 210354
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 | Tablet, ChewableOral | Bryant Ranch Prepack | 72162-1306 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 2.5 mg/1 | Tablet, ChewableOral | Camber Pharmaceuticals Inc. | 31722-926 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | Tablet, ChewableOral | Camber Pharmaceuticals Inc. | 31722-927 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Tablet, ChewableOral | Camber Pharmaceuticals Inc. | 31722-928 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 2.5 mg/1 | Tablet, ChewableOral | XLCare Pharmaceuticals, Inc. | 72865-125 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 5 mg/1 | Tablet, ChewableOral | XLCare Pharmaceuticals, Inc. | 72865-126 |