Prescription drug · ANDA

Sertraline NDC 63187-055

Sertraline hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-055Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0055Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63187-055-306318700553030 TABLET, FILM COATED in 1 BOTTLE (63187-055-30)Marketed from May 1, 2015
63187-055-606318700556060 TABLET, FILM COATED in 1 BOTTLE (63187-055-60)Marketed from May 1, 2015
63187-055-906318700559090 TABLET, FILM COATED in 1 BOTTLE (63187-055-90)Marketed from May 1, 2015

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
Generic name (nonproprietary)
sertraline
Active ingredients
Sertraline hydrochloride — 50 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 63187-055_820641b5-c569-4a24-b0a4-5d17d3cff8eeSPL ID 820641b5-c569-4a24-b0a4-5d17d3cff8eeSPL set ID 35dea1a2-ec26-4e52-8f09-ee4678e77946RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0363187212308, 0363187055301, 0363187478902
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

N463187005530 followed by a unit qualifier and the quantity

Package 63187-0055-30. 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 tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline tablets USP 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 following 8 symptoms: c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077670

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077670
ProductStrengthForm · routeLabelerProduct NDC
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7661
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7662
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP63187-212
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3110
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8596
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3569
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3626
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-3570
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0938
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6924
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4518
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1040
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6925
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7698
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7699
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7700
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7701
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6926
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-075
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0991

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Sertraline NDC 63187-055 | Med-Code