Prescription drug · ANDA
Citalopram (Citalopram hydrobromide) NDC 71610-413
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-413-60 | 7161004136071610041360 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-413-60)Marketed from Apr 3, 2020 |
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
- Generic name (nonproprietary)
- citalopram hydrobromide
- Active ingredients
- Citalopram hydrobromide — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-413_fc10ffe3-e320-4a92-9b34-1f56d369691bSPL ID fc10ffe3-e320-4a92-9b34-1f56d369691bSPL set ID 31ddd184-7560-473c-b674-5fa3187c5598RxCUI 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
N471610041360followed by a unit qualifier and the quantityPackage 71610-0413-60. 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 are indicated for the treatment of depression. The efficacy of citalopram tablets 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 an…
Excerpt only. Read the full label for complete information.
About NDC 71610-413
- What is NDC 71610-413?
- 71610-413 is the product NDC for Citalopram (citalopram hydrobromide), Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Citalopram (Citalopram Hydrobromide).
- What is the active ingredient?
- Citalopram hydrobromide.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
- 91 other product NDCs are listed under this name. See all Citalopram NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Citalopram 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 | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0113 | 67046-0113-03 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0793 | 67046-0793-03 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0795 | 67046-0795-03 |
| Citalopram | Citalopram hydrobromide 30 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-964 | 59651-0964-30 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0557 | 80425-0557-0180425-0557-0280425-0557-03 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4476 | 70518-4476-0070518-4476-01 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4416 | 70518-4416-00 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4335 | 70518-4335-0070518-4335-0170518-4335-02+1 more |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4334 | 70518-4334-0070518-4334-02 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4114 | 70518-4114-01 |
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 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8022 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8023 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8141 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-019 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-670 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3136 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6433 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7039 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7419 |
| 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 | Proficient Rx LP | 63187-140 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-679 |
| 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 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3357 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4114 |
| Citalopramcitalopram hydrobromide | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4334 |
| 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 | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-106 |
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