Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 51407-925
Methylphenidate hydrochloride 27 mg/1 · Tablet, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-925-01 | 5140709250151407092501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-925-01)Marketed from Jun 21, 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
- Generic name (nonproprietary)
- methylphenidate hydrochloride
- Active ingredients
- Methylphenidate hydrochloride — 27 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 51407
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205327
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 51407-925_50289734-e08d-0f5a-e063-6394a90ab421SPL ID 50289734-e08d-0f5a-e063-6394a90ab421SPL set ID 22e5ddfa-7264-fbb1-e063-6394a90a6483RxCUI 1091155, 1091170, 1091185, 1091210UNII 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
N451407092501followed by a unit qualifier and the quantityPackage 51407-0925-01. 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 extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of methylphenidate hydrochloride extended-release tablets 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 ), and Use in Specific Populations ( 8.4 )]. Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of attention deficit hyperactivit…
Excerpt only. Read the full label for complete information.
About NDC 51407-925
- What is NDC 51407-925?
- 51407-925 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate hydrochloride 27 mg/1 tablet, extended release, listed with the FDA by Golden State Medical Supply, 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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 205327
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 18 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-706 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 27 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-707 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-708 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-709 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 72 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-710 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 18 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-924 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 36 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-926 |
| Methylphenidate Hydrochloride | Methylphenidate hydrochloride 54 mg/1 | Tablet, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-927 |