Prescription drug · ANDA
Phentermine Hydrochloride NDC 43547-404
Phentermine hydrochloride 37.5 mg/1 · Tablet · Oral · Solco Healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-404-03 | 4354704040343547040403 | 30 TABLET in 1 BOTTLE, PLASTIC (43547-404-03)Marketed from Jan 4, 2002 | |
| 43547-404-10 | 4354704041043547040410 | 100 TABLET in 1 BOTTLE, PLASTIC (43547-404-10)Marketed from Jan 4, 2002 | |
| 43547-404-11 | 4354704041143547040411 | 1000 TABLET in 1 BOTTLE, PLASTIC (43547-404-11)Marketed from Jan 4, 2017 | |
| 43547-404-50 | 4354704045043547040450 | 500 TABLET in 1 BOTTLE, PLASTIC (43547-404-50)Marketed from Apr 21, 2025 |
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
- Solco Healthcare U.S., LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040377
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 43547-404_e7560e52-6bb6-4f57-be5b-5132bb9f5471SPL ID e7560e52-6bb6-4f57-be5b-5132bb9f5471SPL set ID e4024b8a-25cb-4681-9bb4-44a38c74fe4bRxCUI 803353UNII 0K2I505OTVUPC 0343547404031
- 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
N443547040403followed by a unit qualifier and the quantityPackage 43547-0404-03. 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 tablets are 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 x 0.0254 = meters. The limited useful…
Excerpt only. Read the full label for complete information.
About NDC 43547-404
- What is NDC 43547-404?
- 43547-404 is the product NDC for Phentermine Hydrochloride, Phentermine hydrochloride 37.5 mg/1 tablet, listed with the FDA by Solco Healthcare U.S., LLC. It has 4 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?
- Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 |