Prescription drug · NDA
Qsymia (Phentermine and topiramate) NDC 62541-201
Phentermine hydrochloride 3.75 mg/1; Topiramate 23 mg/1 · Capsule, Extended release · Oral · Vivus LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62541-201-14 | 6254102011462541020114 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14)Marketed from Sep 17, 2012 | |
| 62541-201-30 | 6254102013062541020130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30)Marketed from Sep 17, 2012 |
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)
- Qsymia
- Generic name (nonproprietary)
- phentermine and topiramate
- Active ingredients
- Phentermine hydrochloride — 3.75 mg/1Topiramate — 23 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Vivus LLCNDC labeler code 62541
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022580
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 62541-201_5010eb88-287a-9597-e063-6394a90aad40SPL ID 5010eb88-287a-9597-e063-6394a90aad40SPL set ID 40dd5602-53da-45ac-bb4b-15789aba40f9RxCUI 1302827, 1302833, 1302839, 1302845, 1302850, 1302856, 1313059, 1313061UNII 0K2I505OTV, 0H73WJJ391UPC 0362541202306, 0362541203303, 0362541204300, 0362541201309
- Pharmacologic class
- Sympathomimetic Amine Anorectic
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
N462541020114followed by a unit qualifier and the quantityPackage 62541-0201-14. 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)
QSYMIA is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity Adults with overweight in the presence of at least one weight-related comorbid condition QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with obesity ( 1 ). Adults with overweight in the presence of at least on…
Excerpt only. Read the full label for complete information.
About NDC 62541-201
- What is NDC 62541-201?
- 62541-201 is the product NDC for Qsymia, Phentermine hydrochloride 3.75 mg/1; Topiramate 23 mg/1 capsule, extended release, listed with the FDA by Vivus LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qsymia (Phentermine and topiramate).
- What is the active ingredient?
- Phentermine hydrochloride, Topiramate.
- Who is the labeler?
- Vivus LLC, NDC labeler code 62541. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qsymia?
- 3 other product NDCs are listed under this name. See all Qsymia NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Qsymia products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-202 | 62541-0202-30 |
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-203 | 62541-0203-30 |
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 15 mg/1; Topiramate 92 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-204 | 62541-0204-30 |
Other NDCs under NDA 022580
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 |
|---|---|---|---|---|
| phentermine and topiramate | Phentermine hydrochloride 3.75 mg/1; Topiramate 23 mg/1 | Capsule, Extended releaseOral | Prasco Laboratories | 66993-780 |
| phentermine and topiramate | Phentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1 | Capsule, Extended releaseOral | Prasco Laboratories | 66993-781 |
| phentermine and topiramate | Phentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1 | Capsule, Extended releaseOral | Prasco Laboratories | 66993-782 |
| phentermine and topiramate | Phentermine hydrochloride 15 mg/1; Topiramate 92 mg/1 | Capsule, Extended releaseOral | Prasco Laboratories | 66993-783 |
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-202 |
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-203 |
| Qsymiaphentermine and topiramate | Phentermine hydrochloride 15 mg/1; Topiramate 92 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-204 |