Prescription drug · ANDA
Methylphenidate Hydrochloride NDC 43602-177
Methylphenidate 5 mg/5mL · Solution · Oral · Ascent Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43602-177-05 | 4360201770543602017705 | 500 mL in 1 BOTTLE (43602-177-05)Marketed from Jan 29, 2021 | |
| 43602-177-25 | 4360201772543602017725 | 250 mL in 1 BOTTLE (43602-177-25)Marketed from Jan 29, 2021 |
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 — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Ascent Pharmaceuticals, Inc.NDC labeler code 43602
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207417
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Central Nervous System Stimulation (Physiologic effect)
- Identifiers
- Product ID 43602-177_eadd6980-7aad-464b-9ce8-cf7b1a20064dSPL ID eadd6980-7aad-464b-9ce8-cf7b1a20064dSPL set ID 45ebb59c-9603-4df6-b1be-3295ba2db1e7RxCUI 1091133, 1091341UNII 207ZZ9QZ49UPC 0343602178259, 0343602177252
- 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
N443602017705followed by a unit qualifier and the quantityPackage 43602-0177-05. 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 .
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 is 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 distractibility, short at…
Excerpt only. Read the full label for complete information.
About NDC 43602-177
- What is NDC 43602-177?
- 43602-177 is the product NDC for Methylphenidate Hydrochloride, Methylphenidate 5 mg/5mL solution, listed with the FDA by Ascent Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methylphenidate Hydrochloride.
- What is the active ingredient?
- Methylphenidate.
- Who is the labeler?
- Ascent Pharmaceuticals, Inc., NDC labeler code 43602. 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 | 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 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 63 mg/1 | Tablet, Extended releaseOral | Trigen Laboratories, LLC | 13811-700 | 13811-0700-30 |
Other NDCs under ANDA 207417
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 10 mg/5mL | SolutionOral | Ascent Pharmaceuticals, Inc. | 43602-178 |