Phentermine Hydrochloride NDC 63629-4385

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-4385Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-4385Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
63629-4385-1	63629438501	7 TABLET in 1 BOTTLE (63629-4385-1)Marketed from Apr 2, 2024
63629-4385-2	63629438502	30 TABLET in 1 BOTTLE (63629-4385-2)Marketed from Apr 2, 2024
63629-4385-3	63629438503	14 TABLET in 1 BOTTLE (63629-4385-3)Marketed from Dec 24, 2012
63629-4385-4	63629438504	60 TABLET in 1 BOTTLE (63629-4385-4)Marketed from Apr 2, 2024
63629-4385-5	63629438505	28 TABLET in 1 BOTTLE (63629-4385-5)Marketed from Apr 18, 2013
63629-4385-6	63629438506	24 TABLET in 1 BOTTLE (63629-4385-6)Marketed from Mar 22, 2013
63629-4385-7	63629438507	45 TABLET in 1 BOTTLE (63629-4385-7)Marketed from May 10, 2016
63629-4385-8	63629438508	90 TABLET in 1 BOTTLE (63629-4385-8)Marketed from Dec 4, 2020
63629-4385-9	63629438509	21 TABLET in 1 BOTTLE (63629-4385-9)Marketed from Dec 18, 2015

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 — 37.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040876
Marketing start: Aug 15, 2012
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 63629-4385_07e8afaf-c273-4f13-81fe-1065ec101e71SPL ID 07e8afaf-c273-4f13-81fe-1065ec101e71SPL set ID 2bd5487d-10da-4ae0-9105-273e1a5efdcbRxCUI 803353UNII 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

N463629438501 followed by a unit qualifier and the quantity

Package 63629-4385-01. 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 Aug 20, 2024.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 040876

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 040876
Product	Strength	Form · route	Labeler	Product NDC
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3819
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	KVK-TECH, Inc.	10702-025
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Calvin Scott & Co., Inc.	17224-902
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Martek Pharmacal Co.	84053-025
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	A-S Medication Solutions	50090-1679
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Northwind Health Company, LLC	82868-112
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	55289-701
Phentermine Hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	DirectRx	72189-301