Prescription drug · ANDA

Sertraline Hydrochloride NDC 50090-6613

Sertraline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6613Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6613Add 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
50090-6613-0500906613005009066130030 TABLET, FILM COATED in 1 BOTTLE (50090-6613-0)Marketed from Aug 24, 2023
50090-6613-1500906613015009066130190 TABLET, FILM COATED in 1 BOTTLE (50090-6613-1)Marketed from Aug 24, 2023

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 Hydrochloride
Generic name (nonproprietary)
sertraline hydrochloride
Active ingredients
Sertraline hydrochloride — 25 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 077206
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 50090-6613_61fb2274-36f6-48dc-911b-b9de8d5ac3d0SPL ID 61fb2274-36f6-48dc-911b-b9de8d5ac3d0SPL set ID 90524e6e-c34f-43eb-8c30-d99faf7ae08fRxCUI 312940UNII 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

N450090661300 followed by a unit qualifier and the quantity

Package 50090-6613-00. 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 tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of ( 1 ): Major depressive disorder (MDD) Obsessive-compulsive disorder (OCD) Panic disorder (PD) Posttraumatic stress disorder (PTSD) Social anxiety disorder (SAD) Premenstrual dysphoric disorder (PMDD)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-6613

What is NDC 50090-6613?
50090-6613 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, 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?
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 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 Solutions50090-6614
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 coatedOralQuality Care Products LLC55700-362
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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