Prescription drug · ANDA
Diethylpropion Hydrochloride NDC 84053-044
Diethylpropion hydrochloride 25 mg/1 · Tablet · Oral · Martek Pharmacal Co.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84053-044-21 | 84053004421 | 21 TABLET in 1 BOTTLE (84053-044-21)Marketed from Mar 7, 2024 |
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)
- Diethylpropion Hydrochloride
- Generic name (nonproprietary)
- diethylpropion hydrochloride
- Active ingredients
- Diethylpropion hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Martek Pharmacal Co.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201212
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 84053-044_3a7579c1-0e5e-ac82-e063-6394a90a46a7SPL ID 3a7579c1-0e5e-ac82-e063-6394a90a46a7SPL set ID 130511dc-8f01-02ca-e063-6394a90a671bRxCUI 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
N484053004421followed by a unit qualifier and the quantityPackage 84053-0044-21. 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 & USAGE Diethylpropion hydrochloride is 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 x 0.0254 = meters. Body Mass Index (BMI), kg/m 2 Weight (pounds) Height …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201212
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 | Bryant Ranch Prepack | 71335-1779 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-730 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | KVK-TECH, INC | 10702-044 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-348 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3400 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3836 |