Prescription drug · ANDA
Citalopram Hydrobromide NDC 68788-8962
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8962-1 | 6878889620168788896201 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8962-1)Marketed from Jan 4, 2016 | |
| 68788-8962-3 | 6878889620368788896203 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8962-3)Marketed from Jan 4, 2016 | |
| 68788-8962-6 | 6878889620668788896206 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8962-6)Marketed from Jan 4, 2016 | |
| 68788-8962-8 | 6878889620868788896208 | 120 TABLET, FILM COATED in 1 CARTON (68788-8962-8)Marketed from Jan 4, 2016 | |
| 68788-8962-9 | 6878889620968788896209 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8962-9)Marketed from Jan 4, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-8962_69cb4519-6c41-4519-bebb-66b263e76ea6SPL ID 69cb4519-6c41-4519-bebb-66b263e76ea6SPL set ID 27ddea53-f03d-4760-99bb-ec8efa44ff62RxCUI 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
N468788896201followed by a unit qualifier and the quantityPackage 68788-8962-01. 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.
About NDC 68788-8962
- What is NDC 68788-8962?
- 68788-8962 is the product NDC for Citalopram Hydrobromide, Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 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 | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3349 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3329 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1830 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | Proficient Rx LP | 63187-203 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0113 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1906 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | TabletOral | Proficient Rx LP | 63187-220 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-481 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-221 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4476 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-2198 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0238 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5132 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-043 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6846 |
| Citalopram Hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-0802 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-683 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-091 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-009 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Torrent Pharmaceuticals Limited | 13668-010 |
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