Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 11788-078

Amitriptyline hydrochloride 25 mg/1 · Tablet · Oral · AiPing Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)11788-078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11788-0078Add 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
11788-078-0111788007801100 TABLET in 1 BOTTLE (11788-078-01)Marketed from Nov 1, 2025
11788-078-10117880078101000 TABLET in 1 BOTTLE (11788-078-10)Marketed from Nov 1, 2025

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 — 25 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212654
Marketing start
Listing expires
Identifiers
Product ID 11788-078_4ee04ba3-df06-44c2-8476-09b6cd38f863SPL ID 4ee04ba3-df06-44c2-8476-09b6cd38f863SPL set ID 33807ee6-8443-4613-8bbe-d66f6010fc60RxCUI 856762, 856773, 856783, 856834, 856845, 856853UNII 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

N411788007801 followed by a unit qualifier and the quantity

Package 11788-0078-01. 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)

Other NDCs under ANDA 212654

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

FDA NDC Directory listings under ANDA 212654
ProductStrengthForm · routeLabelerProduct NDC
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-080
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-077
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-079
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-081
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-082
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7599
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4234
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4469
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-390
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-388
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-389
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-391
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-392
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-393
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralBryant Ranch Prepack71335-3151
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7424
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralSt. Mary's Medical Park Pharmacy60760-838
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4330
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-8033
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4366

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Amitriptyline Hydrochloride NDC 11788-078 | Med-Code