What is NDC 76420-108?

76420-108 is the product NDC for Phentermine hydrochloride, Phentermine hydrochloride 37.5 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phentermine hydrochloride NDC 76420-108

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0108Add 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	Copy
76420-108-30	7642001083076420010830	30 TABLET in 1 BOTTLE (76420-108-30)Marketed from Oct 30, 2020

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: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205008
Marketing start: Jan 24, 2017
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Appetite Suppression (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 76420-108_b2ddcdd0-7292-99df-e053-2a95a90a8818SPL ID b2ddcdd0-7292-99df-e053-2a95a90a8818SPL set ID de76ed27-ac43-4923-b73f-461d33941f6bRxCUI 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

N476420010830 followed by a unit qualifier and the quantity

Package 76420-0108-30. 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 Oct 30, 2020.

Indications (excerpt from the label)

Phentermine hydrochloride is 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 usefulness of a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-108

What is NDC 76420-108?: 76420-108 is the product NDC for Phentermine hydrochloride, Phentermine hydrochloride 37.5 mg/1 tablet, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, 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?: Asclemed USA, Inc., NDC labeler code 76420. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Phentermine hydrochloride NDCs
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

All 114 Phentermine hydrochloride NDCs

Other NDCs under ANDA 205008

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

FDA NDC Directory listings under ANDA 205008
Product	Strength	Form · route	Labeler	Product NDC
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	SUNRISE PHARMACEUTICAL, INC.	11534-160
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Calvin Scott & Co., Inc.	17224-904
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Bryant Ranch Prepack	63629-2388
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Bryant Ranch Prepack	63629-2389
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3663
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7906
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Proficient Rx LP	71205-668
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-2297
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-3107
Phentermine hydrochloride	Phentermine hydrochloride 37.5 mg/1	TabletOral	Bryant Ranch Prepack	72162-1229