Prescription drug · ANDA
Lomaira (Phentermine hydrochloride) NDC 10702-001
Phentermine hydrochloride 8 mg/1 · Tablet · Oral · KVK-TECH, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-001-03 | 1070200010310702000103 | 30 TABLET in 1 BOTTLE (10702-001-03)Marketed from Sep 12, 2016 | |
| 10702-001-06 | 1070200010610702000106 | 60 TABLET in 1 BOTTLE (10702-001-06)Marketed from Sep 12, 2016 | |
| 10702-001-09 | 1070200010910702000109 | 90 TABLET in 1 BOTTLE (10702-001-09)Marketed from Sep 12, 2016 | |
| 10702-001-10 | 1070200011010702000110 | 1000 TABLET in 1 BOTTLE (10702-001-10)Marketed from Sep 12, 2016 | |
| 10702-001-25 | 1070200012510702000125 | 250 TABLET in 1 BOTTLE (10702-001-25)Marketed from Sep 12, 2016 | |
| 10702-001-50 | 1070200015010702000150 | 500 TABLET in 1 BOTTLE (10702-001-50)Marketed from Sep 12, 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)
- Lomaira
- Generic name (nonproprietary)
- phentermine hydrochloride
- Active ingredients
- Phentermine hydrochloride — 8 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-TECH, INC.NDC labeler code 10702
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203495
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 10702-001_0ce01306-ef7f-563f-e063-6394a90a52b7SPL ID 0ce01306-ef7f-563f-e063-6394a90a52b7SPL set ID cde9fb09-e5af-434d-8874-e4f9f974d893RxCUI 826919, 1810304UNII 0K2I505OTVUPC 0310702001091
- 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
N410702000103followed by a unit qualifier and the quantityPackage 10702-0001-03. 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)
INDICATIONS AND USAGE LOMAIRA™ 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 in 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 10702-001
- What is NDC 10702-001?
- 10702-001 is the product NDC for Lomaira (phentermine hydrochloride), Phentermine hydrochloride 8 mg/1 tablet, listed with the FDA by KVK-TECH, INC.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lomaira (Phentermine Hydrochloride).
- What is the active ingredient?
- Phentermine hydrochloride.
- Who is the labeler?
- KVK-TECH, INC., NDC labeler code 10702. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lomaira?
- 1 other product NDC are listed under this name. See all Lomaira NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lomaira products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lomairaphentermine hydrochloride | Phentermine hydrochloride 8 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-840 | 17224-0840-2117224-0840-2817224-0840-30+3 more |
Other NDCs under ANDA 203495
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 |
|---|---|---|---|---|
| Lomairaphentermine hydrochloride | Phentermine hydrochloride 8 mg/1 | TabletOral | Calvin Scott & Co., Inc. | 17224-840 |