Prescription drug · ANDA
Diethylpropion Hydrochloride ER (Diethylpropion hydrochloride) NDC 43063-532
Diethylpropion hydrochloride 75 mg/1 · Tablet, Extended release · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-532-07 | 4306305320743063053207 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-07)Marketed from Jun 30, 2014 | |
| 43063-532-14 | 4306305321443063053214 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-14)Marketed from Jun 30, 2014 | |
| 43063-532-21 | 4306305322143063053221 | 21 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-21)Marketed from Dec 19, 2017 | |
| 43063-532-28 | 4306305322843063053228 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-28)Marketed from Nov 14, 2016 | |
| 43063-532-30 | 4306305323043063053230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-532-30)Marketed from Jul 25, 2014 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- diethylpropion hydrochloride
- Active ingredients
- Diethylpropion hydrochloride — 75 mg/1
- Dosage form
- Tablet, Extended release
- 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 091680
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 43063-532_413931e3-aacb-4898-e063-6294a90a5b6bSPL ID 413931e3-aacb-4898-e063-6294a90a5b6bSPL set ID 0d213a24-ebbf-41df-8f32-de44a572829eRxCUI 978668UNII 19V2PL39NGUPC 0343063532072
- 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
N443063053207followed by a unit qualifier and the quantityPackage 43063-0532-07. 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 extended release tablets, 75 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 x 0.0254 = meters. Body Mass Index (B…
Excerpt only. Read the full label for complete information.
About NDC 43063-532
- What is NDC 43063-532?
- 43063-532 is the product NDC for Diethylpropion Hydrochloride ER (diethylpropion hydrochloride), Diethylpropion hydrochloride 75 mg/1 tablet, extended release, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diethylpropion Hydrochloride ER (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 ER?
- 9 other product NDCs are listed under this name. See all Diethylpropion Hydrochloride ER 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 ER 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 ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-109 | 81665-0109-1081665-0109-25 |
| Diethylpropion Hydrochloride ER | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Directrx | 72189-307 | 72189-0307-30 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 0527-1477 | 00527-1477-0100527-1477-25 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Calvin Scott & Co., Inc. | 17224-760 | 17224-0760-0717224-0760-2817224-0760-30+2 more |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-0120 | 50090-0120-0050090-0120-05 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC. | 62135-489 | 62135-0489-30 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-621 | 63187-0621-3063187-0621-6063187-0621-90 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3837 | 68071-3837-01 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0049 | 71335-0049-0171335-0049-0271335-0049-03+6 more |
Other NDCs under ANDA 091680
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 ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Lannett Company, Inc. | 0527-1477 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Calvin Scott & Co., Inc. | 17224-760 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-0120 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Chartwell RX, LLC. | 62135-489 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-621 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3837 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0049 |
| Diethylpropion Hydrochloride ER | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | Directrx | 72189-307 |
| Diethylpropion Hydrochloride ERdiethylpropion hydrochloride | Diethylpropion hydrochloride 75 mg/1 | Tablet, Extended releaseOral | OMNIVIUM PHARMACEUTICALS LLC. | 81665-109 |