What is NDC 71205-912?

71205-912 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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 71205-912

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-912Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0912Add 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
71205-912-00	7120509120071205091200	100 CAPSULE in 1 BOTTLE (71205-912-00)Marketed from Jul 16, 2021
71205-912-11	7120509121171205091211	1000 CAPSULE in 1 BOTTLE (71205-912-11)Marketed from Jul 16, 2021
71205-912-30	7120509123071205091230	30 CAPSULE in 1 BOTTLE (71205-912-30)Marketed from Jul 16, 2021
71205-912-55	7120509125571205091255	500 CAPSULE in 1 BOTTLE (71205-912-55)Marketed from Jul 16, 2021
71205-912-60	7120509126071205091260	60 CAPSULE in 1 BOTTLE (71205-912-60)Marketed from Jul 16, 2021
71205-912-90	7120509129071205091290	90 CAPSULE in 1 BOTTLE (71205-912-90)Marketed from Jul 16, 2021

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 — 75 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211364
Marketing start: Mar 10, 2020
Listing expires: Dec 31, 2027
Identifiers: Product ID 71205-912_be10b430-6ed9-4241-b6d9-818846e80839SPL ID be10b430-6ed9-4241-b6d9-818846e80839SPL set ID ff9ed80e-d692-494f-9741-a9af30fa5000RxCUI 857297, 857301, 857305UNII 2LXW0L6GWJUPC 0371205911607
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

N471205091200 followed by a unit qualifier and the quantity

Package 71205-0912-00. 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 1, 2022. 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 Cl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-912

What is NDC 71205-912?: 71205-912 is the product NDC for Clomipramine Hydrochloride, Clomipramine hydrochloride 75 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 6 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?: Proficient Rx LP, NDC labeler code 71205. 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 211364

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

FDA NDC Directory listings under ANDA 211364
Product	Strength	Form · route	Labeler	Product NDC
Clomipramine Hydrochloride	Clomipramine hydrochloride 75 mg/1	CapsuleOral	Leading Pharma, LLC	69315-165
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Leading Pharma, LLC	69315-166
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Leading Pharma, LLC	69315-167
Clomipramine Hydrochloride	Clomipramine hydrochloride 25 mg/1	CapsuleOral	Proficient Rx LP	71205-910
Clomipramine Hydrochloride	Clomipramine hydrochloride 50 mg/1	CapsuleOral	Proficient Rx LP	71205-911