Prescription drug · ANDA
Benzphetamine Hydrochloride NDC 43063-541
Benzphetamine hydrochloride 50 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-541-14 | 43063054114 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-541-14)Marketed from Oct 22, 2014 | |
| 43063-541-30 | 43063054130 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-541-30)Marketed from Oct 22, 2014 | |
| 43063-541-45 | 43063054145 | 45 TABLET in 1 BOTTLE, PLASTIC (43063-541-45)Marketed from Oct 22, 2014 | |
| 43063-541-60 | 43063054160 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-541-60)Marketed from Oct 22, 2014 | |
| 43063-541-90 | 43063054190 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-541-90)Marketed from Oct 22, 2014 | |
| 43063-541-98 | 43063054198 | 120 TABLET in 1 BOTTLE, PLASTIC (43063-541-98)Marketed from Jul 21, 2010 |
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)
- Benzphetamine Hydrochloride
- Generic name (nonproprietary)
- benzphetamine hydrochloride
- Active ingredients
- Benzphetamine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090968
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 43063-541_41393fbe-29e5-dd10-e063-6394a90a5a13SPL ID 41393fbe-29e5-dd10-e063-6394a90a5a13SPL set ID 2b7014af-0cc9-4199-90f2-ec07ac02f8cfRxCUI 904368UNII 43DWT87QT7UPC 0343063541609
- 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
N443063054114followed by a unit qualifier and the quantityPackage 43063-0541-14. 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)
INDICATIONS AND USAGE Benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. 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. The limited usefulness of agents of this…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090968
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 |
|---|---|---|---|---|
| benzphetamine hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-672 |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | KVK-TECH, INC | 10702-040 |
| Benzphetamine Hydrochloride | Benzphetamine hydrochloride 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0451 |