Prescription drug · ANDA
Phentermine (Phentermine hydrochloride) NDC 13107-105
Phentermine hydrochloride 15 mg/1 · Capsule · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-105-01 | 1310701050113107010501 | 100 CAPSULE in 1 BOTTLE (13107-105-01)Marketed from Mar 20, 2017 | |
| 13107-105-30 | 1310701053013107010530 | 30 CAPSULE in 1 BOTTLE (13107-105-30)Marketed from Mar 20, 2017 |
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
- Generic name (nonproprietary)
- phentermine hydrochloride
- Active ingredients
- Phentermine hydrochloride — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurolife Pharma, LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204318
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 13107-105_53dd7857-41fb-4da1-88f7-5c68a509bfb0SPL ID 53dd7857-41fb-4da1-88f7-5c68a509bfb0SPL set ID 737eef3b-9a6b-4ab3-a25c-49d84d2a0197RxCUI 900038, 968766UNII 0K2I505OTV
- 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
N413107010501followed by a unit qualifier and the quantityPackage 13107-0105-01. 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 Capsules 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 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 = k…
Excerpt only. Read the full label for complete information.
About NDC 13107-105
- What is NDC 13107-105?
- 13107-105 is the product NDC for Phentermine (phentermine hydrochloride), Phentermine hydrochloride 15 mg/1 capsule, listed with the FDA by Aurolife Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Phentermine (Phentermine Hydrochloride).
- What is the active ingredient?
- Phentermine hydrochloride.
- Who is the labeler?
- Aurolife Pharma, LLC, NDC labeler code 13107. 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?
- 2 other product NDCs are listed under this name. See all Phentermine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Phentermine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Phenterminephentermine hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Aurolife Pharma, LLC | 13107-106 | 13107-0106-0113107-0106-30 |
| Phenterminephentermine hydrochloride | Phentermine hydrochloride 37.5 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-890 | 17224-0890-1417224-0890-2117224-0890-28+3 more |
Other NDCs under ANDA 204318
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 |
|---|---|---|---|---|
| Phenterminephentermine hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Aurolife Pharma, LLC | 13107-106 |