Prescription drug · ANDA
Sertraline Hydrochloride NDC 71205-047
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-047-30 | 71205004730 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-047-30)Marketed from Jun 1, 2018 | |
| 71205-047-60 | 71205004760 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-047-60)Marketed from Jun 1, 2018 | |
| 71205-047-90 | 71205004790 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-047-90)Marketed from Jun 1, 2018 |
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)
- Sertraline Hydrochloride
- Generic name (nonproprietary)
- sertraline hydrochloride
- Active ingredients
- Sertraline hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202825
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-047_cbf2683a-b8ea-49b3-a0a0-63c69d70f2fbSPL ID cbf2683a-b8ea-49b3-a0a0-63c69d70f2fbSPL set ID 6b532e6a-b040-4a10-a242-fb6d8dfc0852RxCUI 312938, 312941UNII UTI8907Y6X
- 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
N471205004730followed by a unit qualifier and the quantityPackage 71205-0047-30. 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 Major Depressive Disorder– Sertraline hydrochloride tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the follow…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202825
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 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-855 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-028 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3203 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0415 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-738 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8210 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1078 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0510 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-651 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-092 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-216 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-215 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-217 |