NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3203Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3203Add 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
50090-3203-05009032030030 TABLET, FILM COATED in 1 BOTTLE (50090-3203-0)Marketed from Dec 6, 2017
50090-3203-15009032030160 TABLET, FILM COATED in 1 BOTTLE (50090-3203-1)Marketed from Oct 23, 2017
50090-3203-25009032030290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3203-2)Marketed from Feb 9, 2017

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 — 100 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202825
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 50090-3203_f61fd075-cfd8-468b-814a-2dd2dbb7d02dSPL ID f61fd075-cfd8-468b-814a-2dd2dbb7d02dSPL set ID 14c4fa96-8919-4ea7-ad72-129f288d8cfcRxCUI 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

N450090320300 followed by a unit qualifier and the quantity

Package 50090-3203-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 202825

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

FDA NDC Directory listings under ANDA 202825
ProductStrengthForm · routeLabelerProduct NDC
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.43063-855
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralProficient Rx LP71205-028
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0415
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-738
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8210
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1078
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0510
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-651
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralProficient Rx LP71205-047
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralQPharma, Inc.42708-092
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-216
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-215
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAccord Healthcare, Inc.16729-217

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