Prescription drug · ANDA
Citalopram (citalopram hydrobromide) NDC 82009-108
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · QUALLENT PHARMACEUTICALS HEALTH LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-108-05 | 82009010805 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-108-05)Marketed from Aug 1, 2023 |
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 hydrobromide
- Active ingredients
- Citalopram hydrobromide — 40 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 82009-108_f85b3b65-e283-4270-895c-c601b6e7c6a6SPL ID f85b3b65-e283-4270-895c-c601b6e7c6a6SPL set ID e0822069-9672-4d4c-bc1a-8739b0dd045cRxCUI 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
N482009010805followed by a unit qualifier and the quantityPackage 82009-0108-05. 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)
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Citalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ) .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077031
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3136 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7039 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-679 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-106 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6433 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-107 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7419 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2517 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-605 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3357 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-680 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4334 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-005 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-006 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-007 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0309 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8141 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-670 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-019 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4114 |
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