NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5848Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5848Add 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
50090-5848-0500905848005009058480030 TABLET, FILM COATED in 1 BOTTLE (50090-5848-0)Marketed from Nov 5, 2021
50090-5848-1500905848015009058480190 TABLET, FILM COATED in 1 BOTTLE (50090-5848-1)Marketed from Nov 5, 2021

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 — 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 077670
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 50090-5848_c029a9c5-86c9-43d2-831c-6b9fe1443094SPL ID c029a9c5-86c9-43d2-831c-6b9fe1443094SPL set ID cbc2bd3b-03fc-47b9-91d1-8989ec90c7e6RxCUI 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

N450090584800 followed by a unit qualifier and the quantity

Package 50090-5848-00. 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.

Full label on DailyMed (opens in a new tab)

About NDC 50090-5848

What is NDC 50090-5848?
50090-5848 is the product NDC for Sertraline, 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.
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.

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

Other Sertraline NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418368788-4183-0168788-4183-0368788-4183-06+1 more
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-68360760-0683-90
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442570518-4425-00
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-866968788-8669-0168788-8669-0268788-8669-03+3 more
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-76850268-0768-15
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-76950268-0769-15
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-77050268-0770-15
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75723155-0757-0323155-0757-0523155-0757-09
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75823155-0758-0323155-0758-0523155-0758-09+1 more
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-75923155-0759-0323155-0759-0523155-0759-09

All 32 Sertraline NDCs

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 Solutions50090-7830
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8669
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4590
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7295
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralProficient Rx LP63187-478
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4606
SertralineSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-768
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-769
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-770
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP63187-055
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1617
SertralineSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3534
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAvPAK50268-823
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAvPAK50268-824
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAvPAK50268-825
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralQuality Care Products, LLC55700-225
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-978
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4151
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0153
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralLupin Pharmaceuticals, Inc.68180-986

Showing 20 of 39.

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