What is NDC 72189-581?

72189-581 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 100 mg/1 tablet, 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 72189-581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0581Add 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
72189-581-30	72189058130	30 TABLET in 1 BOTTLE (72189-581-30)Marketed from Sep 19, 2024

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Direct_rxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
Marketing start: Sep 19, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-581_227affe9-36ef-2423-e063-6394a90a58f6SPL ID 227affe9-36ef-2423-e063-6394a90a58f6SPL set ID 227affe9-36ee-2423-e063-6394a90a58f6RxCUI 856762UNII 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

N472189058130 followed by a unit qualifier and the quantity

Package 72189-0581-30. 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 Sep 19, 2024. 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 72189-581

What is NDC 72189-581?: 72189-581 is the product NDC for Amitriptyline HCL, Amitriptyline hydrochloride 100 mg/1 tablet, 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 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 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 217411

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

FDA NDC Directory listings under ANDA 217411
Product	Strength	Form · route	Labeler	Product NDC
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	TabletOral	Major Pharmaceuticals	0904-7410
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	Major Pharmaceuticals	0904-7411
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-105
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-106
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-107
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-108
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-109
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 150 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-110
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	TabletOral	A-S Medication Solutions	50090-7583
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	A-S Medication Solutions	50090-7598
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-685
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-686
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-732
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3656
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4052
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 25 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8691
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8767
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 75 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8788
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 50 mg/1	TabletOral	REMEDYREPACK INC.	70518-4048
Amitriptyline Hydrochloride	Amitriptyline hydrochloride 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4054

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