Prescription drug · ANDA

Citalopram (citalopram hydrobromide) NDC 0615-8023

Citalopram hydrobromide 20 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8023Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8023Add 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
0615-8023-050061580230515 TABLET, FILM COATED in 1 BLISTER PACK (0615-8023-05)Marketed from Oct 28, 2004
0615-8023-390061580233930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8023-39)Marketed from Oct 28, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrobromide
Active ingredients
Citalopram hydrobromide — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077031
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0615-8023_aec16083-ac47-4a94-83ca-412b543f477eSPL ID aec16083-ac47-4a94-83ca-412b543f477eSPL set ID fd761647-e16b-45b3-a4bc-364de0ed7015RxCUI 200371, 283672, 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

N400615802305 followed by a unit qualifier and the quantity

Package 00615-8023-05. 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 Citalopram tablets are indicated for the treatment of depression. The efficacy of citalopram tablets, USP in the treatment of depression was established in 4 to 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 weig…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077031

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

FDA NDC Directory listings under ANDA 077031
ProductStrengthForm · routeLabelerProduct NDC
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3136
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7039
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralProficient Rx LP63187-679
Citalopramcitalopram hydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-106
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6433
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-107
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-108
Citalopramcitalopram hydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7419
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2517
Citalopramcitalopram hydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-605
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3357
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-680
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4334
Citalopramcitalopram hydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-005
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-006
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-007
Citalopram HydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0309
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8141
Citalopramcitalopram hydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-670
Citalopramcitalopram hydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralQPharma, Inc.42708-019

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Citalopram (citalopram hydrobromide) NDC 0615-8023 | Med-Code