Prescription drug · ANDA

Amitriptyline Hydrochloride NDC 69367-388

Amitriptyline hydrochloride 10 mg/1 · Tablet, Coated · Oral · Westminster Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)69367-388Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69367-0388Add 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
69367-388-0169367038801100 TABLET, COATED in 1 BOTTLE (69367-388-01)Marketed from May 20, 2024
69367-388-10693670388101000 TABLET, COATED in 1 BOTTLE (69367-388-10)Marketed from May 20, 2024

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, Coated
Route
Oral
Labeler
Westminster Pharmaceuticals, LLCNDC labeler code 69367
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212654
Marketing start
Listing expires
Identifiers
Product ID 69367-388_3991983c-6f46-46e2-825c-ed9e5d4c1cb4SPL ID 3991983c-6f46-46e2-825c-ed9e5d4c1cb4SPL set ID d46ff585-7082-4a7c-a88f-2acf3be0f1d5RxCUI 856762, 856773, 856783, 856834, 856845, 856853UNII 26LUD4JO9KUPC 0369367391016, 0369367393010, 0369367392013, 0369367388016, 0369367390019, 0369367389013
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

N469367038801 followed by a unit qualifier and the quantity

Package 69367-0388-01. 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 69367-388

What is NDC 69367-388?
69367-388 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 10 mg/1 tablet, coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 2 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?
Westminster Pharmaceuticals, LLC, NDC labeler code 69367. 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 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 10 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-077
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-078
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-079
Amitriptyline HydrochlorideAmitriptyline hydrochloride 75 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-080
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-081
Amitriptyline HydrochlorideAmitriptyline hydrochloride 150 mg/1TabletOralAiPing Pharmaceutical, Inc.11788-082
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7271
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7273
Amitriptyline HydrochlorideAmitriptyline hydrochloride 10 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7424
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralA-S Medication Solutions50090-7599
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1TabletOralA-S Medication Solutions50090-8033
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralSt. Mary's Medical Park Pharmacy60760-838
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-389
Amitriptyline HydrochlorideAmitriptyline hydrochloride 50 mg/1Tablet, CoatedOralWestminster Pharmaceuticals, LLC69367-390
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 10 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4234
Amitriptyline HydrochlorideAmitriptyline hydrochloride 25 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4330
Amitriptyline HydrochlorideAmitriptyline hydrochloride 100 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-4366

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