Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 67046-1669

Amitriptyline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1669Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1669Add 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
67046-1669-36704616690330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1669-3)Marketed from Apr 22, 2026

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)
Amitriptyline Hydrochloride
Generic name (nonproprietary)
amitriptyline hydrochloride
Active ingredients
Amitriptyline hydrochloride — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213999
Marketing start
Listing expires
Identifiers
Product ID 67046-1669_500f1aae-b4a5-b46b-e063-6394a90a8557SPL ID 500f1aae-b4a5-b46b-e063-6394a90a8557SPL set ID 500f239c-0460-a22b-e063-6294a90a1ba6RxCUI 856834UNII 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

N467046166903 followed by a unit qualifier and the quantity

Package 67046-1669-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 67046-1669

What is NDC 67046-1669?
67046-1669 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amitriptyline Hydrochloride.
What is the active ingredient?
Amitriptyline hydrochloride.
Who is the labeler?
Coupler LLC, NDC labeler code 67046. 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 Hydrochloride?
200 other product NDCs are listed under this name. See all Amitriptyline 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 Amitriptyline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-068967046-0689-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169467046-1694-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralCoupler LLC67046-167167046-1671-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-076467046-0764-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81859651-0818-0159651-0818-99
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82259651-0822-01
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81959651-0819-0159651-0819-99
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82059651-0820-01
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-82159651-0821-0159651-0821-60
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralCoupler LLC67046-162567046-1625-03

All 201 Amitriptyline Hydrochloride NDCs

Other NDCs under ANDA 213999

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

FDA NDC Directory listings under ANDA 213999
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HCLAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralDirect_Rx72189-588
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-084
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-334
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-969
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-201
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-202
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-203
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-204
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-205
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralLifestar Pharma LLC70756-206
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9710

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