Prescription drug · ANDA
Citalopram (citalopram hydrobromide) NDC 68071-3357
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3357-1 | 68071335701 | 15 TABLET, FILM COATED in 1 BOTTLE (68071-3357-1)Marketed from Jul 14, 2017 | |
| 68071-3357-3 | 68071335703 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3357-3)Marketed from Jul 14, 2017 | |
| 68071-3357-4 | 68071335704 | 40 TABLET, FILM COATED in 1 BOTTLE (68071-3357-4)Marketed from Jul 14, 2017 | |
| 68071-3357-5 | 68071335705 | 45 TABLET, FILM COATED in 1 BOTTLE (68071-3357-5)Marketed from Jul 14, 2017 | |
| 68071-3357-6 | 68071335706 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3357-6)Marketed from Jul 14, 2017 | |
| 68071-3357-9 | 68071335709 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3357-9)Marketed from Jul 14, 2017 |
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
- Generic name (nonproprietary)
- citalopram hydrobromide
- Active ingredients
- Citalopram hydrobromide — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-3357_3880e5dd-0433-2990-e063-6394a90a0ef8SPL ID 3880e5dd-0433-2990-e063-6394a90a0ef8SPL set ID 544ba802-a536-579a-e054-00144ff88e88RxCUI 309314UNII I1E9D14F36UPC 0368071335798
- 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
N468071335701followed by a unit qualifier and the quantityPackage 68071-3357-01. 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)
INDICATIONS AND USAGE Citalopram tablets, USP are indicated for the treatment of depression. The efficacy of citalopram tablets, USP 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…
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 40 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-108 |
| 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 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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