Prescription drug · ANDA

Sertraline Hydrochloride NDC 60687-253

Sertraline hydrochloride 100 mg/1 · Tablet · Oral · American Health Packaging

NDC codes

FDA NDC Directory
Product NDC (as listed)60687-253Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60687-0253Add 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
60687-253-016068702530160687025301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-253-01) / 1 TABLET in 1 BLISTER PACK (60687-253-11)Marketed from Jun 19, 2017

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
Labeler
American Health PackagingNDC labeler code 60687
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 60687-253_249c2c66-cd55-acd8-e063-6394a90ad0f6SPL ID 249c2c66-cd55-acd8-e063-6394a90ad0f6SPL set ID 4e09f580-d612-416c-a4a4-79a4411845b2RxCUI 312938, 312940, 312941UNII 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

N460687025301 followed by a unit qualifier and the quantity

Package 60687-0253-01. 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)

About NDC 60687-253

What is NDC 60687-253?
60687-253 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, listed with the FDA by American Health Packaging. 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?
American Health Packaging, NDC labeler code 60687. 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 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 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 25 mg/1TabletOralCoupler LLC67046-1181
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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