What is NDC 72189-440?

72189-440 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 3 package NDCs, 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 72189-440 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0440Add 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
72189-440-30	7218904403072189044030	30 TABLET, FILM COATED in 1 BOTTLE (72189-440-30)Marketed from Mar 13, 2023
72189-440-60	7218904406072189044060	60 TABLET, FILM COATED in 1 BOTTLE (72189-440-60)Marketed from Mar 13, 2023
72189-440-90	7218904409072189044090	90 TABLET, FILM COATED in 1 BOTTLE (72189-440-90)Marketed from Mar 13, 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 — 50 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 13, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 72189-440_4c4bd2f1-ee37-e656-e063-6394a90a08d8SPL ID 4c4bd2f1-ee37-e656-e063-6394a90a08d8SPL set ID f6cafc62-6aa9-ca32-e053-6394a90a2086RxCUI 856845UNII 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

N472189044030 followed by a unit qualifier and the quantity

Package 72189-0440-30. 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 Mar 5, 2026. 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 72189-440

What is NDC 72189-440?: 72189-440 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 3 package NDCs, 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 75 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-444	72189-0444-30
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 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 HCl	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-420
Amitriptyline HCL	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-431
Amitriptyline HCL	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-444
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 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
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-423
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 150 mg/1	Tablet, Film coatedOral	Unichem Pharmaceuticals (USA), Inc.	29300-424
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6179
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6313
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6315
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6418
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7513
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	Tablet, Film coatedOral	AvPAK	50268-037
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-038
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-039
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	Tablet, Film coatedOral	AvPAK	50268-040
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-041

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