NDC codes

FDA NDC Directory
Product NDC (as listed)68084-790Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0790Add 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
68084-790-25680840790256808407902530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-790-25) / 1 CAPSULE in 1 BLISTER PACK (68084-790-95)Marketed from Feb 1, 2016

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)
Clomipramine Hydrochloride
Generic name (nonproprietary)
clomipramine hydrochloride
Active ingredients
Clomipramine hydrochloride — 25 mg/1
Dosage form
Capsule
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074694
Marketing start
Listing expires
Identifiers
Product ID 68084-790_25133505-fbef-95cb-e063-6394a90a2aaeSPL ID 25133505-fbef-95cb-e063-6394a90a2aaeSPL set ID 1809bcb4-5fcc-45ca-986a-4fa5edcd4b5eRxCUI 857297, 857301UNII 2LXW0L6GWJ
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

N468084079025 followed by a unit qualifier and the quantity

Package 68084-0790-25. 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 Clomipramine hydrochloride capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68084-790

What is NDC 68084-790?
68084-790 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 25 mg/1 capsule, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Clomipramine Hydrochloride.
What is the active ingredient?
Clomipramine hydrochloride.
Who is the labeler?
American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clomipramine Hydrochloride?
45 other product NDCs are listed under this name. See all Clomipramine 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 Clomipramine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAurobindo Pharma Limited59651-38359651-0383-0159651-0383-3059651-0383-90
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40746708-0407-3046708-0407-3146708-0407-90
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40846708-0408-3046708-0408-3146708-0408-90
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-40946708-0409-3046708-0409-3146708-0409-90
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40762332-0407-3062332-0407-3162332-0407-90
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40862332-0408-3062332-0408-3162332-0408-90
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-40962332-0409-3062332-0409-3162332-0409-90
Clomipramine hydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21027241-0210-0127241-0210-30
Clomipramine hydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21127241-0211-0127241-0211-30
Clomipramine hydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralAjanta Pharma USA Inc.27241-21227241-0212-0127241-0212-30

All 46 Clomipramine Hydrochloride NDCs

Other NDCs under ANDA 074694

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

FDA NDC Directory listings under ANDA 074694
ProductStrengthForm · routeLabelerProduct NDC
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralMajor Pharmaceuticals0904-7038
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralMajor Pharmaceuticals0904-7039
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-757
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-758
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-759
Clomipramine HydrochlorideClomipramine hydrochloride 25 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4011
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4012
Clomipramine HydrochlorideClomipramine hydrochloride 75 mg/1CapsuleOralSun Pharmaceutical Industries, Inc.51672-4013
Clomipramine HydrochlorideClomipramine hydrochloride 50 mg/1CapsuleOralAmerican Health Packaging68084-818

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