Prescription drug · ANDA
Phentermine Hydrochloride NDC 63629-8537
Phentermine hydrochloride 30 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8537-0 | 6362985370063629853700 | 28 CAPSULE in 1 BOTTLE (63629-8537-0)Marketed from Mar 10, 2023 | |
| 63629-8537-1 | 6362985370163629853701 | 30 CAPSULE in 1 BOTTLE (63629-8537-1)Marketed from Mar 10, 2023 | |
| 63629-8537-2 | 6362985370263629853702 | 7 CAPSULE in 1 BOTTLE (63629-8537-2)Marketed from Mar 10, 2023 | |
| 63629-8537-3 | 6362985370363629853703 | 2 CAPSULE in 1 BOTTLE (63629-8537-3)Marketed from Jun 30, 2021 | |
| 63629-8537-4 | 6362985370463629853704 | 60 CAPSULE in 1 BOTTLE (63629-8537-4)Marketed from Mar 10, 2023 | |
| 63629-8537-5 | 6362985370563629853705 | 24 CAPSULE in 1 BOTTLE (63629-8537-5)Marketed from Mar 10, 2023 | |
| 63629-8537-6 | 6362985370663629853706 | 14 CAPSULE in 1 BOTTLE (63629-8537-6)Marketed from Mar 10, 2023 | |
| 63629-8537-7 | 6362985370763629853707 | 42 CAPSULE in 1 BOTTLE (63629-8537-7)Marketed from Mar 10, 2023 | |
| 63629-8537-8 | 6362985370863629853708 | 21 CAPSULE in 1 BOTTLE (63629-8537-8)Marketed from Mar 10, 2023 | |
| 63629-8537-9 | 6362985370963629853709 | 56 CAPSULE in 1 BOTTLE (63629-8537-9)Marketed from Mar 10, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205019
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
- Identifiers
- Product ID 63629-8537_f9bab520-7baa-4cec-84dd-c61d1a86a43dSPL ID f9bab520-7baa-4cec-84dd-c61d1a86a43dSPL set ID fe78b5b4-47bf-484b-ab37-e0d7de6fad57RxCUI 900038UNII 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
N463629853700followed by a unit qualifier and the quantityPackage 63629-8537-00. 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 ≥ 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. BODY MASS INDEX (…
Excerpt only. Read the full label for complete information.
About NDC 63629-8537
- What is NDC 63629-8537?
- 63629-8537 is the product NDC for Phentermine Hydrochloride, Phentermine hydrochloride 30 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 205019
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 15 mg/1 | CapsuleOral | Direct_Rx | 72189-365 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | SUNRISE PHARMACEUTICAL, INC. | 11534-157 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | SUNRISE PHARMACEUTICAL, INC. | 11534-176 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Calvin Scott & Co., Inc. | 17224-851 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5998 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2383 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2384 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2385 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8528 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7740 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-7972 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Proficient Rx LP | 71205-564 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Proficient Rx LP | 71205-785 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1860 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1933 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3017 |
| Phentermine Hydrochloride | Phentermine hydrochloride 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1227 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1231 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | DirectRx | 72189-253 |
| Phentermine Hydrochloride | Phentermine hydrochloride 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-287 |
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