Prescription drug · ANDA
Citalopram NDC 0904-6084
Citalopram hydrobromide 10 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6084-61 | 00904608461 | 100 BLISTER PACK in 1 CARTON (0904-6084-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 2, 2009 |
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
- Active ingredients
- Citalopram hydrobromide — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078216
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6084_5bf8d853-5669-4ef2-940e-6c9075a45ce9SPL ID 5bf8d853-5669-4ef2-940e-6c9075a45ce9SPL set ID a6949652-b15b-435b-9097-2219f398ac05RxCUI 200371, 283672UNII 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
N400904608461followed by a unit qualifier and the quantityPackage 00904-6084-61. 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 is 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 078216
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 |
|---|---|---|---|---|
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | TabletOral | Proficient Rx LP | 63187-220 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1906 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0113 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4476 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-3208 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-043 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-2198 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5132 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0377 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-0802 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0480 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-071 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3384 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-664 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-667 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6846 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6085 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2567 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-481 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0557 |
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