What is NDC 72189-444?

72189-444 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amitriptyline HCL?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amitriptyline HCL NDC 72189-444 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-444Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0444Add 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
72189-444-30	7218904443072189044430	30 TABLET, FILM COATED in 1 BOTTLE (72189-444-30)Marketed from Mar 14, 2023

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): Amitriptyline HCL
Generic name (nonproprietary): amitriptyline hcl
Active ingredients: Amitriptyline hydrochloride — 75 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214548
Marketing start: Mar 14, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-444_2c4d9d53-d060-978d-e063-6294a90ac22dSPL ID 2c4d9d53-d060-978d-e063-6294a90ac22dSPL set ID f6dc463b-3601-48c0-e053-6294a90a2d77RxCUI 856853UNII 26LUD4JO9K
Pharmacologic class: Tricyclic Antidepressant

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

N472189044430 followed by a unit qualifier and the quantity

Package 72189-0444-30. 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 Jan 22, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-444

What is NDC 72189-444?: 72189-444 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 75 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amitriptyline HCL.
What is the active ingredient?: Amitriptyline hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amitriptyline HCL?: 7 other product NDCs are listed under this name. See all Amitriptyline HCL 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 Amitriptyline HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amitriptyline HCL	Amitriptyline hydrochloride 150 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-622	72189-0622-30
Amitriptyline HCL	Amitriptyline hydrochloride 150 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-588	72189-0588-30
Amitriptyline HCL	Amitriptyline hydrochloride 100 mg/1	TabletOral	Direct_rx	72189-581	72189-0581-30
Amitriptyline HCL	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-431	72189-0431-3072189-0431-6072189-0431-90
Amitriptyline HCL	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-440	72189-0440-3072189-0440-6072189-0440-90
Amitriptyline HCl	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-420	72189-0420-3072189-0420-6072189-0420-90
Amitriptyline HCL	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0172	80425-0172-0180425-0172-02

Other NDCs under ANDA 214548

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

FDA NDC Directory listings under ANDA 214548
Product	Strength	Form · route	Labeler	Product NDC
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9668
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6418
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-048
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9685
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-695
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-823
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-092
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-100
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-693
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-694
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-695
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-696
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-697
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 150 mg/1	Tablet, Film coatedOral	Asclemed USA, Inc.	76420-698
Amitriptyline HCL	Amitriptyline hydrochloride 150 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-622
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-419
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-423
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-420
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-421
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-422

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