What is NDC 64850-850?

64850-850 is the product NDC for Trimipramine Maleate, Trimipramine maleate 25 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Elite Laboratories, Inc., NDC labeler code 64850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Trimipramine Maleate?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trimipramine Maleate NDC 64850-850

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-850Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0850Add 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 NDC	11-digit (billing)	Package	Copy
64850-850-30	6485008503064850085030	30 CAPSULE in 1 BOTTLE (64850-850-30)Marketed from Aug 31, 2018

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): Trimipramine Maleate
Generic name (nonproprietary): trimipramine maleate
Active ingredients: Trimipramine maleate — 25 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077361
Marketing start: Nov 21, 2011
Listing expires: Dec 31, 2027
Identifiers: Product ID 64850-850_5aa33d8f-3fbf-4109-8335-c9e8e150e5bcSPL ID 5aa33d8f-3fbf-4109-8335-c9e8e150e5bcSPL set ID 59c25dd3-7ab0-4e7f-b839-367db9eeccd2RxCUI 313496, 313498, 313499UNII 269K6498LDUPC 0364850852302, 0364850851305, 0364850850308
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

N464850085030 followed by a unit qualifier and the quantity

Package 64850-0850-30. 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 Dec 29, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Trimipramine Maleate Capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64850-850

What is NDC 64850-850?: 64850-850 is the product NDC for Trimipramine Maleate, Trimipramine maleate 25 mg/1 capsule, listed with the FDA by Elite Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trimipramine Maleate.
What is the active ingredient?: Trimipramine maleate.
Who is the labeler?: Elite Laboratories, Inc., NDC labeler code 64850. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trimipramine Maleate?: 5 other product NDCs are listed under this name. See all Trimipramine Maleate 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 Trimipramine Maleate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trimipramine Maleate	Trimipramine maleate 50 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-851	64850-0851-30
Trimipramine Maleate	Trimipramine maleate 25 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2061	72162-2061-03
Trimipramine Maleate	Trimipramine maleate 50 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2062	72162-2062-03
Trimipramine Maleate	Trimipramine maleate 100 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-852	64850-0852-30
Trimipramine Maleate	Trimipramine maleate 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2063	72162-2063-03

Other NDCs under ANDA 077361

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

FDA NDC Directory listings under ANDA 077361
Product	Strength	Form · route	Labeler	Product NDC
Trimipramine Maleate	Trimipramine maleate 50 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-851
Trimipramine Maleate	Trimipramine maleate 100 mg/1	CapsuleOral	Elite Laboratories, Inc.	64850-852
Trimipramine Maleate	Trimipramine maleate 25 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2061
Trimipramine Maleate	Trimipramine maleate 50 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2062
Trimipramine Maleate	Trimipramine maleate 100 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-2063