Prescription drug · ANDA
Citalopram NDC 70518-2601
Citalopram hydrobromide 40 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2601-1 | 7051826010170518260101 | 100 POUCH in 1 BOX (70518-2601-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2601-2)Marketed from Apr 16, 2020 | |
| 70518-2601-3 | 7051826010370518260103 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2601-3)Marketed from Apr 16, 2024 |
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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-2601_579a40e5-ed64-65b2-e063-6394a90acec1SPL ID 579a40e5-ed64-65b2-e063-6394a90acec1SPL set ID aa9c1440-354f-43a6-9e70-fd7bafcb03c5RxCUI 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
N470518260101followed by a unit qualifier and the quantityPackage 70518-2601-01. 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 70518-2601
- What is NDC 70518-2601?
- 70518-2601 is the product NDC for Citalopram, Citalopram hydrobromide 40 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | Mylan Pharmaceuticals Inc. | 0378-6233 |
| 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 | Bryant Ranch Prepack | 71335-2232 |