Prescription drug · NDA
Phendimetrazine Tartrate NDC 72989-409
Phendimetrazine tartrate 105 mg/1 · Capsule, Extended release · Oral · Acertis Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72989-409-30 | 72989040930 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72989-409-30)Marketed from Nov 1, 2022 |
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 — 105 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Acertis Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018074
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 72989-409_72552285-ab14-4e9f-957a-d913b31bdd84SPL ID 72552285-ab14-4e9f-957a-d913b31bdd84SPL set ID 162140d3-b833-4633-9759-95821a46a690RxCUI 979543UNII 6985IP0T80UPC 0372989409304
- 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
N472989040930followed by a unit qualifier and the quantityPackage 72989-0409-30. 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)
INDICATIONS AND USAGE Phendimetrazine tartrate extended-release capsules are 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 greater than or equal to 30 kg/m 2 or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia) 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 …
Excerpt only. Read the full label for complete information.
- openFDA data updated
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