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 NDC11-digit (billing)PackageCopy
63629-4385-163629438501636294385017 TABLET in 1 BOTTLE (63629-4385-1)Marketed from Apr 2, 2024
63629-4385-2636294385026362943850230 TABLET in 1 BOTTLE (63629-4385-2)Marketed from Apr 2, 2024
63629-4385-3636294385036362943850314 TABLET in 1 BOTTLE (63629-4385-3)Marketed from Dec 24, 2012
63629-4385-4636294385046362943850460 TABLET in 1 BOTTLE (63629-4385-4)Marketed from Apr 2, 2024
63629-4385-5636294385056362943850528 TABLET in 1 BOTTLE (63629-4385-5)Marketed from Apr 18, 2013
63629-4385-6636294385066362943850624 TABLET in 1 BOTTLE (63629-4385-6)Marketed from Mar 22, 2013
63629-4385-7636294385076362943850745 TABLET in 1 BOTTLE (63629-4385-7)Marketed from May 10, 2016
63629-4385-8636294385086362943850890 TABLET in 1 BOTTLE (63629-4385-8)Marketed from Dec 4, 2020
63629-4385-9636294385096362943850921 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 PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040876
Marketing start
Listing expires
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 .

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)

About NDC 63629-4385

What is NDC 63629-4385?
63629-4385 is the product NDC for Phentermine Hydrochloride, Phentermine hydrochloride 37.5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 9 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.

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

Other Phentermine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC82868-11282868-0112-30
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralAurolife Pharma LLC13107-06113107-0061-0113107-0061-3013107-0061-99
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC82868-05382868-0053-30
Phentermine HydrochloridePhentermine hydrochloride 30 mg/1CapsuleOralMartek Pharmacal Co.84053-02784053-0027-0784053-0027-1484053-0027-21+2 more
Phentermine HydrochloridePhentermine hydrochloride 15 mg/1CapsuleOralMartek Pharmacal Co.84053-02684053-0026-21
Phentermine HydrochloridePhentermine hydrochloride 30 mg/1TabletOralMartek Pharmacal Co.84053-67684053-0676-2184053-0676-28
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralCalvin Scott & Co., Inc.17224-90717224-0907-0717224-0907-1417224-0907-28+6 more
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralPrecision Dose Inc.68094-70268094-0702-5068094-0702-70
Phentermine HydrochloridePhentermine hydrochloride 15 mg/1CapsuleOralPrecision Dose Inc.68094-80268094-0802-5068094-0802-70
Phentermine HydrochloridePhentermine hydrochloride 30 mg/1CapsuleOralPrecision Dose Inc.68094-91068094-0910-5068094-0910-70

All 114 Phentermine Hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralA-S Medication Solutions50090-1679
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralCalvin Scott & Co., Inc.17224-902
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.55289-701
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3819
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralNorthwind Health Company, LLC82868-112
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralMartek Pharmacal Co.84053-025
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralDirectRx72189-301
Phentermine HydrochloridePhentermine hydrochloride 37.5 mg/1TabletOralKVK-TECH, Inc.10702-025

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