Prescription drug · ANDA
Sertraline Hydrochloride NDC 0904-6924
Sertraline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0904-6924Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6924Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6924-61 | 0090469246100904692461 | 100 BLISTER PACK in 1 CARTON (0904-6924-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 6, 2007 |
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)
- Sertraline Hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6924_01e13d2c-21cb-4e08-9512-8fbad50a4f57SPL ID 01e13d2c-21cb-4e08-9512-8fbad50a4f57
- 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
N400904692461followed by a unit qualifier and the quantityPackage 00904-6924-61. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0904-6924
- What is NDC 0904-6924?
- 0904-6924 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sertraline Hydrochloride.
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sertraline Hydrochloride?
- 182 other product NDCs are listed under this name. See all Sertraline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sertraline Hydrochloride | Sertraline hydrochloride 150 mg/1 | Tablet, Film coatedOral | TRUPHARMA, LLC | 52817-223 | 52817-0223-90 |
| Sertraline Hydrochloride | Sertraline hydrochloride 200 mg/1 | Tablet, Film coatedOral | TRUPHARMA, LLC | 52817-224 | 52817-0224-90 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4707 | 70518-4707-0070518-4707-02 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4151 | 68788-4151-0168788-4151-0368788-4151-06+1 more |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | TabletOral | Coupler LLC | 67046-1181 | 67046-1181-03 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-076 | 87441-0076-01 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-077 | 87441-0077-01 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-075 | 87441-0075-01 |
| Sertraline hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1682 | 67046-1682-03 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0555 | 67046-0555-03 |
Other NDCs under ANDA 077670
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 |
|---|---|---|---|---|
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7701 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7700 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7661 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7662 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8596 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-212 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7699 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-311 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7698 |
| Sertralinesertraline hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0989 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-075 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0991 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3626 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3570 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3569 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0938 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8603 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4518 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1040 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8604 |
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