Prescription drug · ANDA
Citalopram NDC 0378-6233
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-6233-01 | 0037862330100378623301 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6233-01)Marketed from Jul 28, 2008 | |
| 0378-6233-05 | 0037862330500378623305 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6233-05)Marketed from Jul 28, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Active ingredients
- Citalopram hydrobromide — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077042
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0378-6233_55e0b75b-3772-4f5b-a162-1f70719daf3dSPL ID 55e0b75b-3772-4f5b-a162-1f70719daf3dSPL set ID 825c0c49-5fbf-6d8b-cb8c-94ebf0eda043RxCUI 200371, 283672, 309314UNII I1E9D14F36UPC 0303786232017, 0303786231010, 0303786233014
- 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
N400378623301followed by a unit qualifier and the quantityPackage 00378-6233-01. 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 tablets are 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 0378-6233
- What is NDC 0378-6233?
- 0378-6233 is the product NDC for Citalopram, Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 077042
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 | Mylan Pharmaceuticals Inc. | 0378-6231 |
| Citalopram | Citalopram hydrobromide 20 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 0378-6232 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3558 |
| Citalopram | Citalopram hydrobromide 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2553 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2601 |
| Citalopram | Citalopram hydrobromide 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2232 |