Prescription drug · ANDA
Phentermine and Topiramate Extended-Release NDC 43598-624
Phentermine hydrochloride 3.75 mg/1; Topiramate 23 mg/1 · Capsule · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-624-30 | 43598062430 | 30 CAPSULE in 1 BOTTLE (43598-624-30)Marketed from Jun 12, 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 Extended-Release
- Generic name (nonproprietary)
- phentermine and topiramate extended-release
- Active ingredients
- Phentermine hydrochloride — 3.75 mg/1Topiramate — 23 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208175
- 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 43598-624_ce37425a-12f1-722f-ab5b-d95615c635a0SPL ID ce37425a-12f1-722f-ab5b-d95615c635a0SPL set ID 260c3f90-163d-0bdd-1099-55d18a900e68RxCUI 1302827, 1302839, 1302850, 1313059UNII 0K2I505OTV, 0H73WJJ391UPC 0343598626307, 0343598624303, 0343598625300
- 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
N443598062430followed by a unit qualifier and the quantityPackage 43598-0624-30. 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: Adult patients 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, over-the-counter drugs, and herbal…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208175
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 Extended-Release | Phentermine hydrochloride 11.25 mg/1; Topiramate 69 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-626 |
| Phentermine and Topiramate Extended-Release | Phentermine hydrochloride 7.5 mg/1; Topiramate 46 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-625 |
| Phentermine and Topiramate Extended-Release | Phentermine hydrochloride 15 mg/1; Topiramate 92 mg/1 | CapsuleOral | Dr.Reddys Laboratories Inc | 43598-627 |