Prescription drug · ANDA
Phendimetrazine Tartrate NDC 64850-440
Phendimetrazine tartrate 35 mg/1 · Tablet · Oral · Elite Laboratories, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-440-01 | 6485004400164850044001 | 100 TABLET in 1 BOTTLE (64850-440-01)Marketed from Nov 20, 2012 | |
| 64850-440-10 | 6485004401064850044010 | 1000 TABLET in 1 BOTTLE (64850-440-10)Marketed from Nov 20, 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)
- Phendimetrazine Tartrate
- Generic name (nonproprietary)
- phendimetrazine tartrate
- Active ingredients
- Phendimetrazine tartrate — 35 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Elite Laboratories, IncNDC labeler code 64850
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040762
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 64850-440_97b69c02-a69e-46fe-8686-4b4d8ceb5dcaSPL ID 97b69c02-a69e-46fe-8686-4b4d8ceb5dcaSPL set ID 42ecacde-6859-47c6-ba44-13fb4f3b5448RxCUI 979549UNII 6985IP0T80UPC 0364850440011, 0364850440103
- 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
N464850044001followed by a unit qualifier and the quantityPackage 64850-0440-01. 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 follow: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inches) …
Excerpt only. Read the full label for complete information.
About NDC 64850-440
- What is NDC 64850-440?
- 64850-440 is the product NDC for Phendimetrazine Tartrate, Phendimetrazine tartrate 35 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phendimetrazine Tartrate.
- What is the active ingredient?
- Phendimetrazine tartrate.
- Who is the labeler?
- Elite Laboratories, Inc, NDC labeler code 64850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Phendimetrazine Tartrate?
- 19 other product NDCs are listed under this name. See all Phendimetrazine Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phendimetrazine Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phendimetrazine Tartrate | Phendimetrazine tartrate 105 mg/1 | Capsule, Extended releaseOral | Acertis Pharmaceuticals, LLC | 72989-409 | 72989-0409-30 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7236 | 68788-7236-0168788-7236-0268788-7236-03+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2489 | 63629-2489-01 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-410 | 69543-0410-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1840 | 71335-1840-0071335-1840-0171335-1840-02+7 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3509 | 68071-3509-0168071-3509-0668071-3509-08+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2044 | 72162-2044-0072162-2044-0172162-2044-03+1 more |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-045 | 10702-0045-0110702-0045-0310702-0045-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-077 | 10702-0077-0110702-0077-0310702-0077-10 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-078 | 10702-0078-0110702-0078-0310702-0078-10 |
Other NDCs under ANDA 040762
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 | NuCare Pharmaceuticals,Inc. | 68071-3509 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2044 |