Prescription drug · ANDA

Sertraline Hydrochloride NDC 55700-362

Sertraline hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Quality Care Products LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55700-362Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55700-0362Add 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
55700-362-90557000362905570003629090 TABLET, FILM COATED in 1 BOTTLE (55700-362-90)Marketed from Aug 25, 2017

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
Quality Care Products LLCNDC labeler code 55700
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077206
Marketing start
Marketing end
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 55700-362_981e0995-fc38-4963-bd59-5f314988fc5cSPL ID 981e0995-fc38-4963-bd59-5f314988fc5cSPL set ID 25aef6c1-9964-44a1-a905-c37e5c28a3c0RxCUI 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

N455700036290 followed by a unit qualifier and the quantity

Package 55700-0362-90. 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 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 55700-362

What is NDC 55700-362?
55700-362 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Quality Care Products LLC. 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?
Quality Care Products LLC, NDC labeler code 55700. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sertraline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sertraline HydrochlorideSertraline hydrochloride 150 mg/1Tablet, Film coatedOralTRUPHARMA, LLC52817-22352817-0223-90
Sertraline HydrochlorideSertraline hydrochloride 200 mg/1Tablet, Film coatedOralTRUPHARMA, LLC52817-22452817-0224-90
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-470770518-4707-0070518-4707-02
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415168788-4151-0168788-4151-0368788-4151-06+1 more
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralCoupler LLC67046-118167046-1181-03
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07687441-0076-01
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07787441-0077-01
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-07587441-0075-01
Sertraline hydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-168267046-1682-03
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralCoupler LLC67046-055567046-0555-03

All 183 Sertraline Hydrochloride NDCs

Other NDCs under ANDA 077206

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

FDA NDC Directory listings under ANDA 077206
ProductStrengthForm · routeLabelerProduct NDC
Sertraline HCLSertraline hydrochloride 50 mg/1Tablet, Film coatedOralDirect_Rx72189-551
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-611
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-612
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-613
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralQPharma Inc42708-124
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-447
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2071
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2080
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6379
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6613
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6614
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6861
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6917
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-173
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-265
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-091
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-612
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-011
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-012
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0554

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