Prescription drug · ANDA
Phentermine Hydrochloride NDC 76420-585
Phentermine hydrochloride 15 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-585-10 | 76420058510 | 100 CAPSULE in 1 BOTTLE (76420-585-10)Marketed from Sep 1, 2023 | |
| 76420-585-30 | 76420058530 | 30 CAPSULE in 1 BOTTLE (76420-585-30)Marketed from Sep 1, 2023 | |
| 76420-585-60 | 76420058560 | 60 CAPSULE in 1 BOTTLE (76420-585-60)Marketed from Sep 1, 2023 | |
| 76420-585-90 | 76420058590 | 90 CAPSULE in 1 BOTTLE (76420-585-90)Marketed from Sep 1, 2023 |
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 — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205019
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 76420-585_04472220-f8f9-1f1a-e063-6294a90a2bb2SPL ID 04472220-f8f9-1f1a-e063-6294a90a2bb2SPL set ID 22683183-a828-47a4-9e52-38175d7c6f21RxCUI 900038, 968766UNII 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
N476420058510followed by a unit qualifier and the quantityPackage 76420-0585-10. 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 capsules 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 ≥ 30 kg/m 2 , or ≥ 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 = kg; inches x 0.0254 = meters. BODY MASS INDEX (…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205019
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 30 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-586 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Proficient Rx LP | 71205-564 |
| Phentermine HCL C-IV | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Direct_Rx | 72189-365 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7972 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-287 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-851 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5998 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-573 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1860 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8528 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | SUNRISE PHARMACEUTICAL, INC. | 11534-157 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8537 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2385 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1933 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2383 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2384 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | DirectRx | 72189-253 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7740 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | SUNRISE PHARMACEUTICAL, INC. | 11534-176 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3017 |
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