NDC codes

FDA NDC Directory
Product NDC (as listed)31722-564Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0564Add 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
31722-564-243172205642431722056424240 mL in 1 BOTTLE (31722-564-24)Marketed from Dec 21, 2015

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 Hydrobromide
Generic name (nonproprietary)
citalopram hydrobromide
Active ingredients
Citalopram hydrobromide — 10 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201450
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 31722-564_1285242d-4c02-8735-e063-6294a90aa6adSPL ID 1285242d-4c02-8735-e063-6294a90aa6adSPL set ID dc7b3f88-ee55-4e3e-9ed4-fc06aa7620ccRxCUI 309313UNII I1E9D14F36UPC 0331722564243
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

N431722056424 followed by a unit qualifier and the quantity

Package 31722-0564-24. 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 oral solution is indicated for the treatment of depression. The efficacy of citalopram oral solution, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-564

What is NDC 31722-564?
31722-564 is the product NDC for Citalopram Hydrobromide, Citalopram hydrobromide 10 mg/5mL solution, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Citalopram Hydrobromide.
What is the active ingredient?
Citalopram hydrobromide.
Who is the labeler?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 Hydrobromide?
28 other product NDCs are listed under this name. See all Citalopram Hydrobromide 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 Hydrobromide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Citalopram HydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-030980425-0309-0180425-0309-0280425-0309-03
Citalopram HydrobromideCitalopram hydrobromide 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-04351655-0043-2651655-0043-52
Citalopram HydrobromideCitalopram hydrobromide 20 mg/1TabletOralQuality Care Products, LLC55700-85155700-0851-90
Citalopram HydrobromideCitalopram hydrobromide 10 mg/1TabletOralQuality Care Products, LLC55700-78755700-0787-3055700-0787-90
Citalopram HydrobromideCitalopram hydrobromide 10 mg/5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-056417856-0564-01
Citalopram HydrobromidecitalopramCitalopram hydrobromide 20 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-09271610-0092-1571610-0092-3071610-0092-45+1 more
Citalopram HydrobromidecitalopramCitalopram hydrobromide 10 mg/1TabletOralExelan Pharmaceuticals Inc.76282-62876282-0628-0576282-0628-1076282-0628-30+1 more
Citalopram HydrobromidecitalopramCitalopram hydrobromide 20 mg/1TabletOralExelan Pharmaceuticals Inc.76282-62976282-0629-0576282-0629-1076282-0629-30+1 more
Citalopram HydrobromideCitalopram hydrobromide 40 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-896268788-8962-0168788-8962-0368788-8962-06+2 more
Citalopram HydrobromideCitalopram hydrobromide 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-080268788-0802-0168788-0802-0368788-0802-06+2 more

All 29 Citalopram Hydrobromide NDCs

Other NDCs under ANDA 201450

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

FDA NDC Directory listings under ANDA 201450
ProductStrengthForm · routeLabelerProduct NDC
Citalopram HydrobromideCitalopram hydrobromide 10 mg/5mLSolutionOralATLANTIC BIOLOGICALS CORP.17856-0564

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