Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 71610-710

Amitriptyline hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)71610-710Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71610-0710Add 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
71610-710-307161007103030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-30)Marketed from Jun 29, 2023
71610-710-537161007105360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-53)Marketed from Jun 29, 2023
71610-710-607161007106090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-60)Marketed from May 31, 2023
71610-710-8071610071080180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-710-80)Marketed from Jun 29, 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 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 089399
Marketing start
Listing expires
Identifiers
Product ID 71610-710_ee8718a4-d803-4a58-9c87-06987c7dd356SPL ID ee8718a4-d803-4a58-9c87-06987c7dd356SPL set ID 4e0f3b15-3621-48a1-9f2b-b0a373920360RxCUI 856783, 856834, 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

N471610071030 followed by a unit qualifier and the quantity

Package 71610-0710-30. 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 . 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)

Other NDCs under ANDA 089399

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

FDA NDC Directory listings under ANDA 089399
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-703
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1254
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1256
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-711
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-688
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-687
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-689
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-690
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-691
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-750
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.57664-692
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-751
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-752
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-795
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-793
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-794
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-796
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-797
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-798

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