NDC codes

FDA NDC Directory
Product NDC (as listed)16714-611Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0611Add 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
16714-611-01167140611011671406110130 TABLET, FILM COATED in 1 BOTTLE (16714-611-01)Marketed from Feb 6, 2007
16714-611-02167140611021671406110260 TABLET, FILM COATED in 1 BOTTLE (16714-611-02)Marketed from Feb 6, 2007
16714-611-03167140611031671406110390 TABLET, FILM COATED in 1 BOTTLE (16714-611-03)Marketed from Feb 6, 2007
16714-611-041671406110416714061104100 TABLET, FILM COATED in 1 BOTTLE (16714-611-04)Marketed from Feb 6, 2007
16714-611-051671406110516714061105500 TABLET, FILM COATED in 1 BOTTLE (16714-611-05)Marketed from Feb 6, 2007
16714-611-0616714061106167140611061000 TABLET, FILM COATED in 1 BOTTLE (16714-611-06)Marketed from Feb 6, 2007

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 — 25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NorthStar Rx LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077206
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 16714-611_8e670c10-d58c-4b50-96b6-9a67331a29c1SPL ID 8e670c10-d58c-4b50-96b6-9a67331a29c1SPL set ID 9bc362d4-489c-4e7f-915a-3076ff8d132aRxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0316714612041, 0316714611044, 0316714613048
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

N416714061101 followed by a unit qualifier and the quantity

Package 16714-0611-01. 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 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) Posttraumatic 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 16714-611

What is NDC 16714-611?
16714-611 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by NorthStar Rx LLC. It has 6 package NDCs, 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?
NorthStar Rx LLC, NDC labeler code 16714. 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 077206

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

FDA NDC Directory listings under ANDA 077206
ProductStrengthForm · routeLabelerProduct NDC
Sertraline HCLSertraline hydrochloride 50 mg/1Tablet, Film coatedOralDirect_Rx72189-551
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-612
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-613
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralQPharma Inc42708-124
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-447
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2071
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2080
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6379
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6613
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6614
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6861
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6917
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-173
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-265
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-362
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-091
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-612
Sertraline HydrochlorideSertraline hydrochloride 25 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-011
Sertraline HydrochlorideSertraline hydrochloride 50 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-012
Sertraline HydrochlorideSertraline hydrochloride 100 mg/1Tablet, Film coatedOralCoupler LLC67046-0554

Showing 20 of 39.

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