Prescription drug · ANDA
Phentermine Hydrochloride NDC 84053-676
Phentermine hydrochloride 30 mg/1 · Tablet · Oral · Martek Pharmacal Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84053-676-21 | 84053067621 | 21 TABLET in 1 BOTTLE (84053-676-21)Marketed from Feb 29, 2024 | |
| 84053-676-28 | 84053067628 | 28 TABLET in 1 BOTTLE (84053-676-28)Marketed from Feb 29, 2024 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Martek Pharmacal Co.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040526
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 84053-676_3a9b6c60-a063-2709-e063-6394a90a6168SPL ID 3a9b6c60-a063-2709-e063-6394a90a6168SPL set ID 12699287-9ca9-07b3-e063-6294a90af21aUNII 0K2I505OTV
- 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
N484053067621followed by a unit qualifier and the quantityPackage 84053-0676-21. 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, USP 37.5 mg is indicated as 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/m2, or greater than or equal to 27 kg/m2 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 = kg;…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040526
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 | A-S Medication Solutions | 50090-1498 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3816 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1312 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0350 |
| Phentermine HCL C-IV | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Direct_Rx | 72189-669 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1106 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1107 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1108 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-901 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-676 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-053 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-596 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Proficient Rx LP | 71205-758 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4919 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1628 |