phentermine and topiramate
- Product NDC
- 66993-780
- 11-digit product format
- 669930780
- Labeler code
- 66993
- Product ID
- 66993-780_52217277-c719-2f2f-e063-6394a90a6699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phentermine and topiramate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Prasco Laboratories
- Application
- NDA022580
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-06-01
- Substance
- PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
- Active strength
- 3.75; 23 mg/1; mg/1
- Pharmacologic classes
- Appetite Suppression [PE], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- phentermine and topiramate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENTERMINE HYDROCHLORIDE | 3.75 mg/1 |
| TOPIRAMATE | 23 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0K2I505OTV, 0H73WJJ391 |
| Rxcui | 1302827, 1302839, 1302850, 1313059 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e5b1b0ba-27f8-4d5d-8943-8aed080fdedc | Product name | 4 | 20260306 |
| 6c26dd6d-01b5-4a80-b096-b3a6f7ca6077 | Product name | 2 | 20250623 |
| cb966f54-bbf0-40fb-b581-80c6648d510c | Product name | 4 | 20250623 |
| 6e2fb0d7-40d7-e97c-1375-fa022ff20193 | Product name | 4 | 20250305 |
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
| 32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab | Product name | 2 | 20230717 |
| ebeae3eb-385d-62da-8827-5ffa80b14e90 | Product name | 2 | 20170810 |
| 1d682039-1122-1cb7-f3f4-c0a028b98748 | Product name | 4 | 20170124 |
| 8ef9ca65-1a6c-7225-351d-36066d0f8e56 | Product name | 3 | 20161229 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66993-780-30 | phentermine and topiramate | 30 in 1 BOTTLE, UNIT-DOSE | CAPSULE, EXTENDED RELEASE | 30 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66993-780-30 | EA - Each | 66993-780 | 9f1d8909-8ec8-4823-bd5f-27b378dc5886 | 1 | 2025-07-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1313059 | phentermine 11.25 MG / topiramate 69 MG 24HR Extended Release Oral Capsule | PSN | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302850 | phentermine 15 MG / topiramate 92 MG 24HR Extended Release Oral Capsule | PSN | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302839 | phentermine 3.75 MG / topiramate 23 MG 24HR Extended Release Oral Capsule | PSN | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302827 | phentermine 7.5 MG / topiramate 46 MG 24HR Extended Release Oral Capsule | PSN | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1313059 | 24 HR phentermine 11.25 MG / topiramate 69 MG Extended Release Oral Capsule | SCD | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302850 | 24 HR phentermine 15 MG / topiramate 92 MG Extended Release Oral Capsule | SCD | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302839 | 24 HR phentermine 3.75 MG / topiramate 23 MG Extended Release Oral Capsule | SCD | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302827 | 24 HR phentermine 7.5 MG / topiramate 46 MG Extended Release Oral Capsule | SCD | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1313059 | phentermine 11.25 MG / topiramate 69 MG 24 HR Extended Release Oral Capsule | SY | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302850 | phentermine 15 MG / topiramate 92 MG 24 HR Extended Release Oral Capsule | SY | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302839 | phentermine 3.75 MG / topiramate 23 MG 24 HR Extended Release Oral Capsule | SY | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
| 1302827 | phentermine 7.5 MG / topiramate 46 MG 24 HR Extended Release Oral Capsule | SY | 876bd763-13fa-481e-b579-c2fc44dbf3c2 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 66993-780-30 | 66993078030 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (66993-780-30) | 2025-06-01 | No | No | Current |