Prescription drug · ANDA

Sertraline Hydrochloride NDC 68645-523

Sertraline hydrochloride 100 mg/1 · Tablet · Oral · Legacy Pharmaceutical Packaging, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)68645-523Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68645-0523Add 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
68645-523-546864505235430 TABLET in 1 BOTTLE (68645-523-54)Marketed from Jul 21, 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 — 100 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
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68645-523_4cc29310-2a31-9e2e-e063-6294a90a8e5dSPL ID 4cc29310-2a31-9e2e-e063-6294a90a8e5dSPL set ID bd86b293-dab9-4d37-95eb-2bffca335d16RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0368645522548, 0368645521541, 0368645523545
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

N468645052354 followed by a unit qualifier and the quantity

Package 68645-0523-54. 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 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 tablets are 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)

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/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 50 mg/1TabletOralProficient Rx LP63187-767
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

Showing 20 of 26.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Sertraline Hydrochloride NDC 68645-523 | Med-Code