Prescription drug · ANDA
Phentermine Hydrochloride NDC 43063-596
Phentermine hydrochloride 30 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-596-01 | 4306305960143063059601 | 100 TABLET in 1 BOTTLE, PLASTIC (43063-596-01)Marketed from Sep 26, 2022 | |
| 43063-596-07 | 4306305960743063059607 | 7 TABLET in 1 BOTTLE, PLASTIC (43063-596-07)Marketed from Aug 6, 2015 | |
| 43063-596-14 | 4306305961443063059614 | 14 TABLET in 1 BOTTLE, PLASTIC (43063-596-14)Marketed from Aug 6, 2015 | |
| 43063-596-15 | 4306305961543063059615 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-596-15)Marketed from Aug 6, 2015 | |
| 43063-596-21 | 4306305962143063059621 | 21 TABLET in 1 BOTTLE, PLASTIC (43063-596-21)Marketed from Aug 6, 2015 | |
| 43063-596-28 | 4306305962843063059628 | 28 TABLET in 1 BOTTLE, PLASTIC (43063-596-28)Marketed from Aug 6, 2015 | |
| 43063-596-30 | 4306305963043063059630 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-596-30)Marketed from Aug 6, 2015 | |
| 43063-596-32 | 4306305963243063059632 | 32 TABLET in 1 BOTTLE, PLASTIC (43063-596-32)Marketed from Jul 27, 2022 | |
| 43063-596-42 | 4306305964243063059642 | 42 TABLET in 1 BOTTLE, PLASTIC (43063-596-42)Marketed from Aug 6, 2015 | |
| 43063-596-45 | 4306305964543063059645 | 45 TABLET in 1 BOTTLE, PLASTIC (43063-596-45)Marketed from Aug 6, 2015 | |
| 43063-596-60 | 4306305966043063059660 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-596-60)Marketed from Aug 6, 2015 | |
| 43063-596-90 | 4306305969043063059690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-596-90)Marketed from Aug 6, 2015 | |
| 43063-596-93 | 4306305969343063059693 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-596-93)Marketed from Aug 6, 2015 |
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)
- Phentermine Hydrochloride
- Generic name (nonproprietary)
- phentermine hydrochloride
- Active ingredients
- Phentermine hydrochloride — 30 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 040526
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 43063-596_4139a2e1-0cbe-32df-e063-6394a90a346eSPL ID 4139a2e1-0cbe-32df-e063-6394a90a346eSPL set ID abf702d6-6f94-48dc-ad23-c52fd74e83a8UNII 0K2I505OTVUPC 0343063596456
- 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
N443063059601followed by a unit qualifier and the quantityPackage 43063-0596-01. 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)
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). 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. BODY MASS INDEX (BMI), kg/m…
Excerpt only. Read the full label for complete information.
About NDC 43063-596
- What is NDC 43063-596?
- 43063-596 is the product NDC for Phentermine Hydrochloride, Phentermine hydrochloride 30 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 13 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phentermine Hydrochloride.
- What is the active ingredient?
- Phentermine 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 Phentermine Hydrochloride?
- 113 other product NDCs are listed under this name. See all Phentermine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phentermine 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) |
|---|---|---|---|---|---|
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-112 | 82868-0112-30 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Aurolife Pharma LLC | 13107-061 | 13107-0061-0113107-0061-3013107-0061-99 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-053 | 82868-0053-30 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Martek Pharmacal Co. | 84053-027 | 84053-0027-0784053-0027-1484053-0027-21+2 more |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Martek Pharmacal Co. | 84053-026 | 84053-0026-21 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Martek Pharmacal Co. | 84053-676 | 84053-0676-2184053-0676-28 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-907 | 17224-0907-0717224-0907-1417224-0907-28+6 more |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Precision Dose Inc. | 68094-702 | 68094-0702-5068094-0702-70 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Precision Dose Inc. | 68094-802 | 68094-0802-5068094-0802-70 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Precision Dose Inc. | 68094-910 | 68094-0910-5068094-0910-70 |
Other NDCs under ANDA 040526
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 |
|---|---|---|---|---|
| Phentermine HCL C-IV | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Direct_Rx | 72189-669 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-901 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1498 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 53489-676 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1106 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1107 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1108 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3816 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4919 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Proficient Rx LP | 71205-758 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0350 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1312 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1628 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-053 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | TabletOral | Martek Pharmacal Co. | 84053-676 |