Prescription drug · ANDA
Citalopram NDC 80425-0093
Citalopram hydrobromide 20 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0093-1 | 8042500930180425009301 | 30 TABLET in 1 BOTTLE (80425-0093-1)Marketed from Oct 18, 2007 | |
| 80425-0093-2 | 8042500930280425009302 | 60 TABLET in 1 BOTTLE (80425-0093-2)Marketed from Oct 18, 2007 |
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
- Active ingredients
- Citalopram hydrobromide — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- 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 80425-0093_2a996b2b-b5d6-65e7-e063-6394a90adeedSPL ID 2a996b2b-b5d6-65e7-e063-6394a90adeedSPL set ID b3541f26-dc8d-6591-e053-2995a90a23d9RxCUI 200371UNII 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
N480425009301followed by a unit qualifier and the quantityPackage 80425-0093-01. 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 Section INDICATIONS AND USAGE Citalopram, is indicated for the treatment of depression. The efficacy of citalopram hydrobromide, 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, sign…
Excerpt only. Read the full label for complete information.
About NDC 80425-0093
- What is NDC 80425-0093?
- 80425-0093 is the product NDC for Citalopram, Citalopram hydrobromide 20 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Citalopram.
- What is the active ingredient?
- Citalopram hydrobromide.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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 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 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2567 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-071 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-495 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4416 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | Proficient Rx LP | 71205-764 |
| Citalopram Hydrobromide | Citalopram hydrobromide 10 mg/1 | TabletOral | Quality Care Products, LLC | 55700-787 |
| Citalopram Hydrobromide | Citalopram hydrobromide 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-3208 |
| 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 20 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-220 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-219 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | ASCLEMED USA INC. | 87063-221 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3329 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3349 |
| 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 |
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