Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 16729-171

Amitriptyline hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16729-171Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0171Add 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
16729-171-0116729017101100 TABLET, FILM COATED in 1 BOTTLE (16729-171-01)Marketed from Dec 18, 2014
16729-171-17167290171171000 TABLET, FILM COATED in 1 BOTTLE (16729-171-17)Marketed from Dec 5, 2014

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 Hydrochloride
Generic name (nonproprietary)
amitriptyline hydrochloride
Active ingredients
Amitriptyline hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202446
Marketing start
Listing expires
Identifiers
Product ID 16729-171_387e8b29-cf4d-4859-e063-6294a90ad470SPL ID 387e8b29-cf4d-4859-e063-6294a90ad470
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

N416729017101 followed by a unit qualifier and the quantity

Package 16729-0171-01. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 202446

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

FDA NDC Directory listings under ANDA 202446
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0395
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralProficient Rx LP63187-637
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-632
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0566
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3564
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4092
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4104
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-175
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-176
Amitriptyline HCLAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0172

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Amitriptyline Hydrochloride NDC 16729-171 | Med-Code