What is NDC 16571-683?

16571-683 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 25 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clomipramine Hydrochloride NDC 16571-683

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-683Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0683Add 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
16571-683-01	1657106830116571068301	100 CAPSULE in 1 BOTTLE (16571-683-01)Marketed from Nov 1, 2020
16571-683-03	1657106830316571068303	30 CAPSULE in 1 BOTTLE (16571-683-03)Marketed from Nov 1, 2020
16571-683-09	1657106830916571068309	90 CAPSULE in 1 BOTTLE (16571-683-09)Marketed from Nov 1, 2020

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: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212285
Marketing start: Nov 1, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 16571-683_90156b43-61b5-41ef-87e9-e044f5864a2eSPL ID 90156b43-61b5-41ef-87e9-e044f5864a2eSPL set ID bf37fdc5-f579-48c9-baa3-8e516ac71a33RxCUI 857297, 857301, 857305UNII 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

N416571068301 followed by a unit qualifier and the quantity

Package 16571-0683-01. 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 Apr 17, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clomipramine hydrochloride capsules USP is 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 egodystonic. 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 Clo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-683

What is NDC 16571-683?: 16571-683 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 25 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-383	59651-0383-0159651-0383-3059651-0383-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-407	46708-0407-3046708-0407-3146708-0407-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-408	46708-0408-3046708-0408-3146708-0408-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-409	46708-0409-3046708-0409-3146708-0409-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-407	62332-0407-3062332-0407-3162332-0407-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-408	62332-0408-3062332-0408-3162332-0408-90
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-409	62332-0409-3062332-0409-3162332-0409-90
Clomipramine hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Ajanta Pharma USA Inc.	27241-210	27241-0210-0127241-0210-30
Clomipramine hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Ajanta Pharma USA Inc.	27241-211	27241-0211-0127241-0211-30
Clomipramine hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Ajanta Pharma USA Inc.	27241-212	27241-0212-0127241-0212-30

All 46 Clomipramine Hydrochloride NDCs

Other NDCs under ANDA 212285

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

FDA NDC Directory listings under ANDA 212285
Product	Strength	Form · route	Labeler	Product NDC
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-684
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-685