Prescription drug · ANDA
Phentermine hydrochloride NDC 71335-0646
Phentermine hydrochloride 37.5 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0646-0 | 71335064600 | 56 CAPSULE in 1 BOTTLE (71335-0646-0)Marketed from Dec 17, 2018 | |
| 71335-0646-1 | 71335064601 | 14 CAPSULE in 1 BOTTLE (71335-0646-1)Marketed from Feb 12, 2018 | |
| 71335-0646-2 | 71335064602 | 7 CAPSULE in 1 BOTTLE (71335-0646-2)Marketed from Jul 6, 2018 | |
| 71335-0646-3 | 71335064603 | 30 CAPSULE in 1 BOTTLE (71335-0646-3)Marketed from Feb 12, 2018 | |
| 71335-0646-4 | 71335064604 | 50 CAPSULE in 1 BOTTLE (71335-0646-4)Marketed from Jan 28, 2025 | |
| 71335-0646-5 | 71335064605 | 90 CAPSULE in 1 BOTTLE (71335-0646-5)Marketed from Jan 28, 2025 | |
| 71335-0646-6 | 71335064606 | 120 CAPSULE in 1 BOTTLE (71335-0646-6)Marketed from Jan 28, 2025 | |
| 71335-0646-7 | 71335064607 | 21 CAPSULE in 1 BOTTLE (71335-0646-7)Marketed from Jan 28, 2025 | |
| 71335-0646-8 | 71335064608 | 28 CAPSULE in 1 BOTTLE (71335-0646-8)Marketed from Feb 24, 2020 | |
| 71335-0646-9 | 71335064609 | 60 CAPSULE in 1 BOTTLE (71335-0646-9)Marketed from Jan 28, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205017
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71335-0646_1b4cff1c-1c47-4331-a0d7-c773c5a8f34bSPL ID 1b4cff1c-1c47-4331-a0d7-c773c5a8f34bSPL set ID 86a6ce50-673d-4031-87a0-51965cc1e795RxCUI 803348UNII 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
N471335064600followed by a unit qualifier and the quantityPackage 71335-0646-00. 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 is 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. The limited usefulness of a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205017
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 | CapsuleOral | Bryant Ranch Prepack | 71335-2296 |
| Phentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | CapsuleOral | SUNRISE PHARMACEUTICAL, INC. | 11534-159 |
| Phentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2386 |
| Phentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2387 |
| Phentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1228 |