Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 68788-8346

Amitriptyline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8346Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8346Add 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
68788-8346-168788834601100 TABLET, FILM COATED in 1 BOTTLE (68788-8346-1)Marketed from Feb 6, 2023
68788-8346-36878883460330 TABLET, FILM COATED in 1 BOTTLE (68788-8346-3)Marketed from Feb 6, 2023
68788-8346-66878883460660 TABLET, FILM COATED in 1 BOTTLE (68788-8346-6)Marketed from Feb 6, 2023
68788-8346-86878883460828 TABLET, FILM COATED in 1 BOTTLE (68788-8346-8)Marketed from Feb 6, 2023
68788-8346-96878883460990 TABLET, FILM COATED in 1 BOTTLE (68788-8346-9)Marketed from Feb 6, 2023

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214548
Marketing start
Listing expires
Identifiers
Product ID 68788-8346_b3b83604-2c2a-4ff9-941a-c8670cfeb460SPL ID b3b83604-2c2a-4ff9-941a-c8670cfeb460SPL set ID ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26RxCUI 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

N468788834601 followed by a unit qualifier and the quantity

Package 68788-8346-01. 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 68788-8346

What is NDC 68788-8346?
68788-8346 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 214548

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

FDA NDC Directory listings under ANDA 214548
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HClAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralDirect_Rx72189-420
Amitriptyline HCLAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralDirect_Rx72189-431
Amitriptyline HCLAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralDirect_Rx72189-440
Amitriptyline HCLAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralDirect_Rx72189-444
Amitriptyline HCLAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralDirect_Rx72189-622
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-419
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-420
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-421
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-422
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-423
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-424
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6179
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6313
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6315
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6418
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7513
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, Film coatedOralAvPAK50268-037
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-038
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-039
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, Film coatedOralAvPAK50268-040

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