Prescription drug · ANDA
Phentermine Hydrochloride NDC 71335-0161
Phentermine hydrochloride 37.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0161-0 | 71335016100 | 90 TABLET in 1 BOTTLE (71335-0161-0)Marketed from Mar 8, 2011 | |
| 71335-0161-1 | 71335016101 | 30 TABLET in 1 BOTTLE (71335-0161-1)Marketed from Mar 8, 2011 | |
| 71335-0161-2 | 71335016102 | 15 TABLET in 1 BOTTLE (71335-0161-2)Marketed from Mar 8, 2011 | |
| 71335-0161-3 | 71335016103 | 28 TABLET in 1 BOTTLE (71335-0161-3)Marketed from Mar 8, 2011 | |
| 71335-0161-4 | 71335016104 | 7 TABLET in 1 BOTTLE (71335-0161-4)Marketed from Mar 8, 2011 | |
| 71335-0161-5 | 71335016105 | 14 TABLET in 1 BOTTLE (71335-0161-5)Marketed from Mar 8, 2011 | |
| 71335-0161-6 | 71335016106 | 60 TABLET in 1 BOTTLE (71335-0161-6)Marketed from Mar 8, 2011 | |
| 71335-0161-7 | 71335016107 | 45 TABLET in 1 BOTTLE (71335-0161-7)Marketed from Mar 8, 2011 | |
| 71335-0161-8 | 71335016108 | 2 TABLET in 1 BOTTLE (71335-0161-8)Marketed from Mar 8, 2011 | |
| 71335-0161-9 | 71335016109 | 21 TABLET in 1 BOTTLE (71335-0161-9)Marketed from Mar 8, 2011 |
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
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200272
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 71335-0161_098e240a-c834-444a-a56c-933a6a102df5SPL ID 098e240a-c834-444a-a56c-933a6a102df5SPL set ID bd7393cb-2b72-4ecd-ba03-801b635b7647RxCUI 803353UNII 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
N471335016100followed by a unit qualifier and the quantityPackage 71335-0161-00. 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 Tablets 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 × 0.0254 = meters. BODY MASS INDEX (B…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200272
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 | Bryant Ranch Prepack | 63629-2477 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3808 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Precision Dose Inc. | 68094-702 |
| Phentermine HCLphentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-905 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-907 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | TAGI Pharma, Inc. | 51224-101 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2488 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1562 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-433 |