Prescription drug · ANDA
Phentermine Hydrochloride NDC 55289-701
Phentermine hydrochloride 37.5 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-701-07 | 5528907010755289070107 | 7 TABLET in 1 BOTTLE, PLASTIC (55289-701-07)Marketed from Sep 29, 2015 | |
| 55289-701-14 | 5528907011455289070114 | 14 TABLET in 1 BOTTLE, PLASTIC (55289-701-14)Marketed from Sep 29, 2015 | |
| 55289-701-15 | 5528907011555289070115 | 15 TABLET in 1 BOTTLE, PLASTIC (55289-701-15)Marketed from Sep 29, 2015 | |
| 55289-701-21 | 5528907012155289070121 | 21 TABLET in 1 BOTTLE, PLASTIC (55289-701-21)Marketed from Sep 29, 2015 | |
| 55289-701-28 | 5528907012855289070128 | 28 TABLET in 1 BOTTLE, PLASTIC (55289-701-28)Marketed from Sep 29, 2015 | |
| 55289-701-30 | 5528907013055289070130 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-701-30)Marketed from Sep 29, 2015 | |
| 55289-701-32 | 5528907013255289070132 | 32 TABLET in 1 BOTTLE, PLASTIC (55289-701-32)Marketed from Sep 29, 2015 | |
| 55289-701-42 | 5528907014255289070142 | 42 TABLET in 1 BOTTLE, PLASTIC (55289-701-42)Marketed from Dec 15, 2016 | |
| 55289-701-45 | 5528907014555289070145 | 45 TABLET in 1 BOTTLE, PLASTIC (55289-701-45)Marketed from Sep 29, 2015 | |
| 55289-701-56 | 5528907015655289070156 | 56 TABLET in 1 BOTTLE, PLASTIC (55289-701-56)Marketed from Oct 24, 2016 | |
| 55289-701-60 | 5528907016055289070160 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-701-60)Marketed from Sep 29, 2015 | |
| 55289-701-90 | 5528907019055289070190 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-701-90)Marketed from Sep 29, 2015 | |
| 55289-701-98 | 5528907019855289070198 | 120 TABLET in 1 BOTTLE, PLASTIC (55289-701-98)Marketed from Dec 15, 2016 |
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 — 37.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040876
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 55289-701_419b433d-1cbf-6c27-e063-6294a90a155cSPL ID 419b433d-1cbf-6c27-e063-6294a90a155cSPL set ID 68fcc228-5f06-4ece-94f3-59b5b33c3325RxCUI 803353UNII 0K2I505OTVUPC 0355289701286
- 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
N455289070107followed by a unit qualifier and the quantityPackage 55289-0701-07. 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)
Phentermine hydrochloride, USP 37.5 mg is indicated as 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 greater than or equal to 30 kg/m 2 , or greater than or equal to 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 = …
Excerpt only. Read the full label for complete information.
About NDC 55289-701
- What is NDC 55289-701?
- 55289-701 is the product NDC for Phentermine Hydrochloride, Phentermine hydrochloride 37.5 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 55289. 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 040876
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 Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1679 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-902 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3819 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-112 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Martek Pharmacal Co. | 84053-025 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | DirectRx | 72189-301 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | KVK-TECH, Inc. | 10702-025 |
| Phentermine Hydrochloride | Phentermine hydrochloride 37.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4385 |