Prescription drug · ANDA

Sertraline Hydrochloride NDC 63187-767

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

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-767Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0767Add 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
63187-767-306318707673030 TABLET in 1 BOTTLE (63187-767-30)Marketed from Nov 1, 2016
63187-767-606318707676060 TABLET in 1 BOTTLE (63187-767-60)Marketed from Nov 1, 2016
63187-767-906318707679090 TABLET in 1 BOTTLE (63187-767-90)Marketed from Nov 1, 2016

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 — 50 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077397
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 63187-767_bf653681-ada4-416d-83f8-9a69044da4c0SPL ID bf653681-ada4-416d-83f8-9a69044da4c0SPL set ID 551d5946-00df-4608-96a2-b29f0ef93ba0RxCUI 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

N463187076730 followed by a unit qualifier and the quantity

Package 63187-0767-30. 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 is 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 following 8 sympto…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077397

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

FDA NDC Directory listings under ANDA 077397
ProductStrengthForm · routeLabelerProduct NDC
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-769
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-049
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralBryant Ranch Prepack71335-0328
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-050
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-818
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-522
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-521
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-033
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-523
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4658
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralCipla USA Inc.69097-835
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralCipla USA Inc.69097-833
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralCipla USA Inc.69097-834
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralREMEDYREPACK INC.70518-4307
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralCardinal Health 107, LLC55154-4692
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-4687
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralProficient Rx LP63187-795
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-886
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralAmerican Health Packaging60687-231
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralAmerican Health Packaging60687-242

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