Prescription drug · ANDA
Citalopram Hydrobromide (Citalopram) NDC 76282-629
Citalopram hydrobromide 20 mg/1 · Tablet · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-629-05 | 7628206290576282062905 | 500 TABLET in 1 BOTTLE (76282-629-05)Marketed from Nov 10, 2017 | |
| 76282-629-10 | 7628206291076282062910 | 1000 TABLET in 1 BOTTLE (76282-629-10)Marketed from Nov 10, 2017 | |
| 76282-629-30 | 7628206293076282062930 | 30 TABLET in 1 BOTTLE (76282-629-30)Marketed from Nov 10, 2017 | |
| 76282-629-90 | 7628206299076282062990 | 90 TABLET in 1 BOTTLE (76282-629-90)Marketed from Nov 10, 2017 |
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
- Active ingredients
- Citalopram hydrobromide — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals Inc.NDC labeler code 76282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077534
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 76282-629_fd69f24e-8108-4b9e-92ca-13ebbdf86e45SPL ID fd69f24e-8108-4b9e-92ca-13ebbdf86e45SPL set ID a8e8fde2-8392-4d5b-902b-e2b9dd55a02dRxCUI 200371, 283672, 309314UNII I1E9D14F36UPC 0376282208909, 0376282629902, 0376282628905
- 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
N476282062905followed by a unit qualifier and the quantityPackage 76282-0629-05. 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 is 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.
About NDC 76282-629
- What is NDC 76282-629?
- 76282-629 is the product NDC for Citalopram Hydrobromide (citalopram), Citalopram hydrobromide 20 mg/1 tablet, listed with the FDA by Exelan Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Citalopram Hydrobromide (Citalopram).
- What is the active ingredient?
- Citalopram hydrobromide.
- Who is the labeler?
- Exelan Pharmaceuticals Inc., NDC labeler code 76282. 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 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 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-0802 | 68788-0802-0168788-0802-0368788-0802-06+2 more |
Other NDCs under ANDA 077534
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 | Citalopram hydrobromide 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-938 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-412 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-208 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2228 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Cipla USA Inc. | 69097-822 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Cipla USA Inc. | 69097-823 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Cipla USA Inc. | 69097-824 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-137 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-209 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-628 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5170 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-092 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-5172 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-5175 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2617 |
| Citalopram Hydrobromidecitalopram | Citalopram hydrobromide 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-112 |