Prescription drug · ANDA
Citalopram Hydrobromide NDC 65862-074
Citalopram hydrobromide 10 mg/5mL · Solution · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-074-24 | 6586200742465862007424 | 240 mL in 1 BOTTLE (65862-074-24)Marketed from Aug 28, 2006 |
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
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077812
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-074_7cecadcf-9da0-41e4-b9fd-0fe04572dcd8SPL ID 7cecadcf-9da0-41e4-b9fd-0fe04572dcd8SPL set ID e7a2cbdd-1bdb-4e59-a3dd-298a189753aeRxCUI 309313UNII 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
N465862007424followed by a unit qualifier and the quantityPackage 65862-0074-24. 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, USP is indicated for the treatment of depression. The efficacy of citalopram oral solution, 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, significan…
Excerpt only. Read the full label for complete information.
About NDC 65862-074
- What is NDC 65862-074?
- 65862-074 is the product NDC for Citalopram Hydrobromide, Citalopram hydrobromide 10 mg/5mL solution, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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.
Related NDCs: other Citalopram Hydrobromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0309 | 80425-0309-0180425-0309-0280425-0309-03 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-043 | 51655-0043-2651655-0043-52 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | Quality Care Products, LLC | 55700-851 | 55700-0851-90 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | TabletOral | Quality Care Products, LLC | 55700-787 | 55700-0787-3055700-0787-90 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0564 | 17856-0564-01 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-092 | 71610-0092-1571610-0092-3071610-0092-45+1 more |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-628 | 76282-0628-0576282-0628-1076282-0628-30+1 more |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-629 | 76282-0629-0576282-0629-1076282-0629-30+1 more |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8962 | 68788-8962-0168788-8962-0368788-8962-06+2 more |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-564 | 31722-0564-24 |