Prescription drug · ANDA
Phendimetrazine Tartrate NDC 66267-394
Phendimetrazine tartrate 35 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66267-394-60 | 6626703946066267039460 | 60 TABLET in 1 BOTTLE (66267-394-60)Marketed from Nov 9, 2016 |
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
- NuCare Pharmaceuticals, Inc,NDC labeler code 66267
- 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 66267-394_1fa6afe6-d924-02d3-e063-6394a90a41c7SPL ID 1fa6afe6-d924-02d3-e063-6394a90a41c7SPL set ID 40e5b0bf-347e-30f6-e054-00144ff88e88RxCUI 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
N466267039460followed by a unit qualifier and the quantityPackage 66267-0394-60. 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. BODY MASS INDEX (BMI), kg/m 2 Height (feet, inche…
Excerpt only. Read the full label for complete information.
About NDC 66267-394
- What is NDC 66267-394?
- 66267-394 is the product NDC for Phendimetrazine Tartrate, Phendimetrazine tartrate 35 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc,. It has 1 package NDC, 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?
- NuCare Pharmaceuticals, Inc,, NDC labeler code 66267. 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 | Elite Laboratories, Inc | 64850-440 | 64850-0440-0164850-0440-10 |
| 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 |
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 | KVK-TECH, INC | 10702-045 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-077 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | KVK-TECH, INC | 10702-078 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-800 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-510 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-0715 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-2235 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | A-S Medication Solutions | 50090-6552 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3839 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7236 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0074 |
| Phendimetrazine Tartrate | Phendimetrazine tartrate 35 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0324 |