Prescription drug · ANDA
Phendimetrazine Tartrate NDC 10702-078
Phendimetrazine tartrate 35 mg/1 · Tablet · Oral · KVK-TECH, INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-078-01 | 10702007801 | 100 TABLET in 1 BOTTLE (10702-078-01)Marketed from Sep 15, 2010 | |
| 10702-078-03 | 10702007803 | 30 TABLET in 1 BOTTLE (10702-078-03)Marketed from Sep 15, 2010 | |
| 10702-078-10 | 10702007810 | 1000 TABLET in 1 BOTTLE (10702-078-10)Marketed from Sep 15, 2010 |
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)
- Phendimetrazine Tartrate
- Generic name (nonproprietary)
- phendimetrazine tartrate
- Active ingredients
- Phendimetrazine tartrate — 35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-TECH, INC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091042
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 10702-078_289ebb0b-370d-4ea1-e063-6394a90a1752SPL ID 289ebb0b-370d-4ea1-e063-6394a90a1752SPL set ID 07bf3488-09e7-436f-af3f-94c35a7be025RxCUI 979549UNII 6985IP0T80
- 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
N410702007801followed by a unit qualifier and the quantityPackage 10702-0078-01. 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: Phendimetrazine tartrate is indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. Phendimetrazine tartrate is indicated for use as …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091042
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 |
|---|---|---|---|---|
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0324 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-800 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-0715 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7236 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-045 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-2235 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-510 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0074 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-6552 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-077 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc, | 66267-394 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3839 |