Prescription drug · ANDA
Diethylpropion Hydrochloride NDC 50090-2580
Diethylpropion hydrochloride 25 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2580-4 | 50090258004 | 28 TABLET in 1 BOTTLE (50090-2580-4)Marketed from Dec 12, 2016 | |
| 50090-2580-5 | 50090258005 | 90 TABLET in 1 BOTTLE (50090-2580-5)Marketed from Dec 12, 2016 | |
| 50090-2580-7 | 50090258007 | 60 TABLET in 1 BOTTLE (50090-2580-7)Marketed from Jan 31, 2017 | |
| 50090-2580-8 | 50090258008 | 30 TABLET in 1 BOTTLE (50090-2580-8)Marketed from Oct 31, 2016 |
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)
- Diethylpropion Hydrochloride
- Generic name (nonproprietary)
- diethylpropion hydrochloride
- Active ingredients
- Diethylpropion hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200177
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 50090-2580_71fc069a-2c49-479c-8df1-6b890ad9a224SPL ID 71fc069a-2c49-479c-8df1-6b890ad9a224SPL set ID 7f4eca5b-f850-44fc-88b4-4d9bcdf2ba44RxCUI 978654UNII 19V2PL39NG
- 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
N450090258004followed by a unit qualifier and the quantityPackage 50090-2580-04. 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 Diethylpropion hydrochloride tablets USP, 25 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches × 0.0254 = meters. Body Mass Index (BMI), kg/m 2 W…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200177
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 |
|---|---|---|---|---|
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-947 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-488 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1475 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-117 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0175 |