Prescription drug · ANDA
Methylphenidate Hydrochloride (LA) (Methylphenidate hydrochloride) NDC 75907-053
Methylphenidate hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-053-30 | 7590700533075907005330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (75907-053-30)Marketed from Dec 20, 2024 |
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 (LA)
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories IncNDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078458
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 75907-053_256aeb9c-b91a-46b9-35fc-94648f5f585cSPL ID 256aeb9c-b91a-46b9-35fc-94648f5f585cSPL set ID d8c14df4-ac05-d69d-9308-58a51d568329RxCUI 1806177, 1806179, 1806183, 1806185, 1806195UNII 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
N475907005330followed by a unit qualifier and the quantityPackage 75907-0053-30. 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 extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies (14) ] . Limitation of Use The use of Methylphenidate hydrochloride extended-release capsules (LA) is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations (8.4)]. Methylphenidate hydrochloride extended-release capsules (LA) is a central nervous system (CNS…
Excerpt only. Read the full label for complete information.
About NDC 75907-053
- What is NDC 75907-053?
- 75907-053 is the product NDC for Methylphenidate Hydrochloride (LA), Methylphenidate hydrochloride 60 mg/1 capsule, extended release, listed with the FDA by Dr. Reddy's Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylphenidate Hydrochloride (LA) (Methylphenidate Hydrochloride).
- What is the active ingredient?
- Methylphenidate hydrochloride.
- Who is the labeler?
- Dr. Reddy's Laboratories Inc, NDC labeler code 75907. 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 (LA)?
- 4 other product NDCs are listed under this name. See all Methylphenidate Hydrochloride (LA) 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 (LA) 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 (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 10 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-049 | 75907-0049-01 |
| Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-050 | 75907-0050-01 |
| Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-051 | 75907-0051-01 |
| Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-052 | 75907-0052-01 |
Other NDCs under ANDA 078458
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 (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 20 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-050 |
| Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 30 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-051 |
| Methylphenidate Hydrochloride (LA)methylphenidate hydrochloride | Methylphenidate hydrochloride 40 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-052 |