Prescription drug · ANDA

Sertraline Hydrochloride NDC 67046-1181

Sertraline hydrochloride 25 mg/1 · Tablet · Oral · Coupler LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67046-1181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67046-1181Add 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
67046-1181-3670461181036704611810330 TABLET in 1 BLISTER PACK (67046-1181-3)Marketed from Jul 10, 2026

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
Route
Oral
Labeler
Coupler LLCNDC labeler code 67046
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 67046-1181_56441779-943e-9d34-e063-6394a90ae7a7SPL ID 56441779-943e-9d34-e063-6394a90ae7a7SPL set ID 56442b06-c135-a035-e063-6394a90a171bRxCUI 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

N467046118103 followed by a unit qualifier and the quantity

Package 67046-1181-03. 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) 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 67046-1181

What is NDC 67046-1181?
67046-1181 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, listed with the FDA by Coupler 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?
Coupler LLC, NDC labeler code 67046. 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 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
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-055467046-0554-03

All 183 Sertraline Hydrochloride NDCs

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
SertralineSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-818
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-033
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-754
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralNorthwind Health Company, LLC51655-345
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralCardinal Health 107, LLC55154-4687
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralCardinal Health 107, LLC55154-4692
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralAmerican Health Packaging60687-231
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralAmerican Health Packaging60687-242
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralAmerican Health Packaging60687-253
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralProficient Rx LP63187-767
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralProficient Rx LP63187-795
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralProficient Rx LP63187-859
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4658
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-521
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-522
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralLegacy Pharmaceutical Packaging, LLC68645-523
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1TabletOralCipla USA Inc.69097-833
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1TabletOralCipla USA Inc.69097-834
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1TabletOralCipla USA Inc.69097-835

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