Prescription drug · ANDA
Citalopram Hydrobromide (Citalopram) NDC 43353-112
Citalopram hydrobromide 40 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-112-15 | 4335301121543353011215 | 15 TABLET in 1 BOTTLE (43353-112-15)Marketed from Oct 9, 2015 | |
| 43353-112-30 | 4335301123043353011230 | 30 TABLET in 1 BOTTLE (43353-112-30)Marketed from Oct 9, 2015 | |
| 43353-112-45 | 4335301124543353011245 | 45 TABLET in 1 BOTTLE (43353-112-45)Marketed from Oct 9, 2015 | |
| 43353-112-53 | 4335301125343353011253 | 60 TABLET in 1 BOTTLE (43353-112-53)Marketed from Oct 9, 2015 | |
| 43353-112-60 | 4335301126043353011260 | 90 TABLET in 1 BOTTLE (43353-112-60)Marketed from Oct 9, 2015 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- 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 43353-112_4c38f808-9a23-b5b5-e063-6394a90ae44bSPL ID 4c38f808-9a23-b5b5-e063-6394a90ae44bSPL set ID 7307df53-d570-4e26-971d-e97522ccce7fRxCUI 200371, 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
N443353011215followed by a unit qualifier and the quantityPackage 43353-0112-15. 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 tablets, USP are indicated for the treatment of depression. The efficacy of citalopram 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, significant change in weight and/o…
Excerpt only. Read the full label for complete information.
About NDC 43353-112
- What is NDC 43353-112?
- 43353-112 is the product NDC for Citalopram Hydrobromide (citalopram), Citalopram hydrobromide 40 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 5 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 |
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 | Exelan Pharmaceuticals Inc. | 76282-629 |
| 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 |