Prescription drug · ANDA
Sertraline NDC 50090-0991
Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0991-0 | 5009009910050090099100 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0991-0)Marketed from Nov 28, 2014 | |
| 50090-0991-1 | 5009009910150090099101 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-0991-1)Marketed from Nov 28, 2014 | |
| 50090-0991-2 | 5009009910250090099102 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-0991-2)Marketed from Nov 28, 2014 |
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)
- Sertraline
- Generic name (nonproprietary)
- sertraline
- Active ingredients
- Sertraline hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-0991_da44577b-8f80-407b-8dae-d65a14118edeSPL ID da44577b-8f80-407b-8dae-d65a14118edeSPL set ID b2533b60-cc54-4905-a4ee-ea08a160f8c6RxCUI 312938UNII 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
N450090099100followed by a unit qualifier and the quantityPackage 50090-0991-00. 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)
Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14 )] : Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Post-traumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)
Excerpt only. Read the full label for complete information.
About NDC 50090-0991
- What is NDC 50090-0991?
- 50090-0991 is the product NDC for Sertraline, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sertraline.
- What is the active ingredient?
- Sertraline hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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?
- 31 other product NDCs are listed under this name. See all Sertraline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sertraline 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 | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4183 | 68788-4183-0168788-4183-0368788-4183-06+1 more |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-683 | 60760-0683-90 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4425 | 70518-4425-00 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8669 | 68788-8669-0168788-8669-0268788-8669-03+3 more |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-768 | 50268-0768-15 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-769 | 50268-0769-15 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-770 | 50268-0770-15 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-757 | 23155-0757-0323155-0757-0523155-0757-09 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-758 | 23155-0758-0323155-0758-0523155-0758-09+1 more |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-759 | 23155-0759-0323155-0759-0523155-0759-09 |
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 | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5848 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7830 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8669 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4590 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7295 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-478 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4606 |
| Sertraline | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-768 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-769 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-770 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-055 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1617 |
| Sertraline | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3534 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-823 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-824 |
| Sertraline Hydrochloride | Sertraline hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-825 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 55700-225 |
| Sertraline Hydrochloride | Sertraline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-978 |
| Sertraline Hydrochloride | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4151 |
| Sertraline | Sertraline hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0153 |
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