Phendimetrazine Tartrate NDC 64850-440

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0440Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
64850-440-01	64850044001	100 TABLET in 1 BOTTLE (64850-440-01)Marketed from Nov 20, 2012
64850-440-10	64850044010	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, Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040762
Marketing start: Nov 20, 2012
Listing expires: Dec 31, 2026
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

N464850044001 followed by a unit qualifier and the quantity

Package 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 Feb 7, 2019.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040762

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040762
Product	Strength	Form · route	Labeler	Product NDC
Phendimetrazine Tartrate	Phendimetrazine tartrate 35 mg/1	TabletOral	Bryant Ranch Prepack	72162-2044
Phendimetrazine Tartrate	Phendimetrazine tartrate 35 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3509