Prescription drug · ANDA
Diethylpropion Hydrochloride NDC 43063-348
Diethylpropion hydrochloride 25 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-348-01 | 4306303480143063034801 | 100 TABLET in 1 BOTTLE, PLASTIC (43063-348-01)Marketed from Mar 7, 2012 | |
| 43063-348-07 | 4306303480743063034807 | 7 TABLET in 1 BOTTLE, PLASTIC (43063-348-07)Marketed from Mar 7, 2012 | |
| 43063-348-14 | 4306303481443063034814 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-348-14)Marketed from Mar 7, 2012 | |
| 43063-348-21 | 4306303482143063034821 | 21 TABLET in 1 BOTTLE, PLASTIC (43063-348-21)Marketed from Mar 7, 2012 | |
| 43063-348-28 | 4306303482843063034828 | 28 TABLET in 1 BOTTLE, PLASTIC (43063-348-28)Marketed from Mar 7, 2012 | |
| 43063-348-30 | 4306303483043063034830 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-348-30)Marketed from Mar 7, 2012 | |
| 43063-348-56 | 4306303485643063034856 | 56 TABLET in 1 BOTTLE, PLASTIC (43063-348-56)Marketed from Mar 7, 2012 | |
| 43063-348-60 | 4306303486043063034860 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-348-60)Marketed from Mar 7, 2012 | |
| 43063-348-90 | 4306303489043063034890 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-348-90)Marketed from Mar 7, 2012 | |
| 43063-348-93 | 4306303489343063034893 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-348-93)Marketed from Mar 7, 2012 |
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
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- 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 43063-348_41379e71-36e8-db5a-e063-6394a90a63aeSPL ID 41379e71-36e8-db5a-e063-6394a90a63aeSPL set ID ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10RxCUI 978654UNII 19V2PL39NGUPC 0343063348604
- 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
N443063034801followed by a unit qualifier and the quantityPackage 43063-0348-01. 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.
About NDC 43063-348
- What is NDC 43063-348?
- 43063-348 is the product NDC for Diethylpropion Hydrochloride, Diethylpropion hydrochloride 25 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 10 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diethylpropion Hydrochloride.
- What is the active ingredient?
- Diethylpropion hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diethylpropion Hydrochloride?
- 12 other product NDCs are listed under this name. See all Diethylpropion Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diethylpropion Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Martek Pharmacal Co. | 84053-044 | 84053-0044-21 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1475 | 00527-1475-01 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-2580 | 50090-2580-0450090-2580-0550090-2580-07+1 more |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Chartwell RX, LLC. | 62135-488 | 62135-0488-90 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Proficient Rx LP | 63187-947 | 63187-0947-2163187-0947-3063187-0947-60+1 more |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0175 | 71335-0175-0071335-0175-0171335-0175-02+7 more |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-117 | 72789-0117-2872789-0117-90 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | KVK-TECH, INC | 10702-044 | 10702-0044-0110702-0044-0310702-0044-06 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-730 | 17224-0730-2817224-0730-3017224-0730-56+3 more |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3400 | 68071-3400-0068071-3400-0168071-3400-02+4 more |
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 | KVK-TECH, INC | 10702-044 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-730 |
| 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 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1779 |
| Diethylpropion Hydrochloride | Diethylpropion hydrochloride 25 mg/1 | TabletOral | Martek Pharmacal Co. | 84053-044 |