Prescription drug · ANDA
Phentermine Hydrochloride NDC 63187-800
Phentermine hydrochloride 37.5 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-800-07 | 63187080007 | 7 TABLET in 1 BOTTLE (63187-800-07)Marketed from Jan 2, 2017 | |
| 63187-800-14 | 63187080014 | 14 TABLET in 1 BOTTLE (63187-800-14)Marketed from Jun 29, 2021 | |
| 63187-800-15 | 63187080015 | 15 TABLET in 1 BOTTLE (63187-800-15)Marketed from Jan 2, 2017 | |
| 63187-800-30 | 63187080030 | 30 TABLET in 1 BOTTLE (63187-800-30)Marketed from Jan 2, 2017 | |
| 63187-800-60 | 63187080060 | 60 TABLET in 1 BOTTLE (63187-800-60)Marketed from Jan 2, 2017 |
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)
- Phentermine Hydrochloride
- Generic name (nonproprietary)
- phentermine hydrochloride
- Active ingredients
- Phentermine hydrochloride — 37.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203068
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 63187-800_4e1cdc95-3d6c-4a43-8aec-194daf2abd12SPL ID 4e1cdc95-3d6c-4a43-8aec-194daf2abd12SPL set ID b3c48b3c-fab7-4ea4-93b0-b108979e9da3RxCUI 803353UNII 0K2I505OTVUPC 0363187800307
- 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
N463187080007followed by a unit qualifier and the quantityPackage 63187-0800-07. 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)
Phentermine hydrochloride tablets USP are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 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). 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203068
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 |
|---|---|---|---|---|
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-061 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | DIRECT RX | 72189-203 |