Prescription drug · NDA AUTHORIZED GENERIC
phentermine and topiramate NDC 66993-783
Phentermine hydrochloride 15 mg/1; Topiramate 92 mg/1 · Capsule, Extended release · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-783-30 | 66993078330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-783-30)Marketed from Jun 1, 2025 |
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)
- phentermine and topiramate
- Generic name (nonproprietary)
- phentermine and topiramate
- Active ingredients
- Phentermine hydrochloride — 15 mg/1Topiramate — 92 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Prasco Laboratories
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication 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 66993-783_52217277-c719-2f2f-e063-6394a90a6699SPL ID 52217277-c719-2f2f-e063-6394a90a6699SPL set ID 876bd763-13fa-481e-b579-c2fc44dbf3c2RxCUI 1302827, 1302839, 1302850, 1313059UNII 0K2I505OTV, 0H73WJJ391UPC 0366993783307, 0366993782300, 0366993781303, 0366993780306
- 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
N466993078330followed by a unit qualifier and the quantityPackage 66993-0783-30. 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 .
Indications (excerpt from the label)
Phentermine and topiramate extended-release capsules are 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 Limitations of Use The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other products intended for weight loss, including prescription drugs,…
Excerpt only. Read the full label for complete information.
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 11.25 mg/1; Topiramate 69 mg/1 | Capsule, Extended releaseOral | Prasco Laboratories | 66993-782 |
| 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 |
| 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 3.75 mg/1; Topiramate 23 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-201 |
| 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 15 mg/1; Topiramate 92 mg/1 | Capsule, Extended releaseOral | Vivus LLC | 62541-204 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.