What is NDC 71610-422?

71610-422 is the product NDC for Citalopram, Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Citalopram?

91 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Citalopram NDC 71610-422 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0422Add 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
71610-422-45	7161004224571610042245	45 TABLET, FILM COATED in 1 BOTTLE (71610-422-45)Marketed from May 1, 2020
71610-422-60	7161004226071610042260	90 TABLET, FILM COATED in 1 BOTTLE (71610-422-60)Marketed from May 18, 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): Citalopram
Generic name (nonproprietary): citalopram
Active ingredients: Citalopram hydrobromide — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077045
Marketing start: May 20, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71610-422_5b7791df-471c-4407-a795-ad43aba3142dSPL ID 5b7791df-471c-4407-a795-ad43aba3142dSPL set ID 3d70380f-ef97-4de9-a8f8-44ef9ba7e5a7RxCUI 309314UNII I1E9D14F36
Pharmacologic class: Serotonin Reuptake Inhibitor

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

N471610042245 followed by a unit qualifier and the quantity

Package 71610-0422-45. 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 May 13, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Citalopram tablets are indicated for the treatment of depression. The efficacy of citalopram tablets in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-422

What is NDC 71610-422?: 71610-422 is the product NDC for Citalopram, Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Citalopram.
What is the active ingredient?: Citalopram hydrobromide.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Citalopram?: 91 other product NDCs are listed under this name. See all Citalopram 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 Citalopram NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Citalopram	Citalopram hydrobromide 40 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0113	67046-0113-03
Citalopram	Citalopram hydrobromide 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0793	67046-0793-03
Citalopram	Citalopram hydrobromide 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0795	67046-0795-03
Citalopram	Citalopram hydrobromide 30 mg/1	CapsuleOral	Aurobindo Pharma Limited	59651-964	59651-0964-30
Citalopram	Citalopram hydrobromide 10 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0557	80425-0557-0180425-0557-0280425-0557-03
Citalopram	Citalopram hydrobromide 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4476	70518-4476-0070518-4476-01
Citalopram	Citalopram hydrobromide 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4416	70518-4416-00
Citalopram	Citalopram hydrobromide 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4335	70518-4335-0070518-4335-0170518-4335-02+1 more
Citalopramcitalopram hydrobromide	Citalopram hydrobromide 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4334	70518-4334-0070518-4334-02
Citalopramcitalopram hydrobromide	Citalopram hydrobromide 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4114	70518-4114-01

All 92 Citalopram NDCs

Other NDCs under ANDA 077045

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

FDA NDC Directory listings under ANDA 077045
Product	Strength	Form · route	Labeler	Product NDC
Citalopram	Citalopram hydrobromide 10 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-019
Citalopram	Citalopram hydrobromide 20 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-020
Citalopram	Citalopram hydrobromide 40 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-021
Citalopram	Citalopram hydrobromide 40 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-175