Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 80425-0395

Amitriptyline hydrochloride 25 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0395Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0395Add 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
80425-0395-18042503950130 TABLET in 1 BOTTLE (80425-0395-1)Marketed from May 24, 2024
80425-0395-28042503950260 TABLET in 1 BOTTLE (80425-0395-2)Marketed from May 24, 2024
80425-0395-38042503950390 TABLET in 1 BOTTLE (80425-0395-3)Marketed from May 24, 2024

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
Route
Oral
Labeler
Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
Marketing start
Listing expires
Identifiers
Product ID 80425-0395_273326d2-b8f4-466a-e063-6294a90a7abbSPL ID 273326d2-b8f4-466a-e063-6294a90a7abbSPL set ID 19b0c015-c07f-63b7-e063-6394a90a6060RxCUI 856762, 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

N480425039501 followed by a unit qualifier and the quantity

Package 80425-0395-01. 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 . 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 80425-0395

What is NDC 80425-0395?
80425-0395 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, 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?
Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 100 mg/1Tablet, Film coatedOralCoupler LLC67046-169467046-1694-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralCoupler LLC67046-068967046-0689-03
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 coatedOralCoupler LLC67046-166967046-1669-03
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited59651-81859651-0818-0159651-0818-99
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 coatedOralAurobindo Pharma Limited59651-82259651-0822-01

All 201 Amitriptyline Hydrochloride NDCs

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
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0439
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralREMEDYREPACK INC.70518-4054
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralREMEDYREPACK INC.70518-4365
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-4088
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8691
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralAdvanced Rx of Tennessee, LLC80425-0434
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralA-S Medication Solutions50090-7583
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralA-S Medication Solutions50090-7598
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8767
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8788
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-685
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralBryant Ranch Prepack71335-2374
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-686
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralRising Pharma Holdings, Inc.16571-108
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-105
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralRising Pharma Holdings, Inc.16571-106
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralRising Pharma Holdings, Inc.16571-107
Amitriptyline HCLAmitriptyline hydrochloride 100 mg/1TabletOralDirect_rx72189-581
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralRising Pharma Holdings, Inc.16571-109
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1TabletOralRising Pharma Holdings, Inc.16571-110

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Amitriptyline Hydrochloride NDC 80425-0395 | Med-Code