What is NDC 72189-551?

72189-551 is the product NDC for Sertraline HCL, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 HCL?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sertraline HCL NDC 72189-551 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-551Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0551Add 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 NDC	11-digit (billing)	Package	Copy
72189-551-30	7218905513072189055130	30 TABLET, FILM COATED in 1 BOTTLE (72189-551-30)Marketed from May 1, 2024
72189-551-90	7218905519072189055190	90 TABLET, FILM COATED in 1 BOTTLE (72189-551-90)Marketed from May 1, 2024

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 HCL
Generic name (nonproprietary): sertraline hcl
Active ingredients: Sertraline hydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077206
Marketing start: May 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 72189-551_1894b61a-705c-a0c2-e063-6394a90afdbaSPL ID 1894b61a-705c-a0c2-e063-6394a90afdbaSPL set ID 1766ea8b-bb88-8bb8-e063-6394a90a032dRxCUI 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

N472189055130 followed by a unit qualifier and the quantity

Package 72189-0551-30. 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 May 16, 2024. 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)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-551

What is NDC 72189-551?: 72189-551 is the product NDC for Sertraline HCL, Sertraline hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sertraline HCL.
What is the active ingredient?: Sertraline hydrochloride.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. 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 HCL?: 8 other product NDCs are listed under this name. See all Sertraline HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sertraline HClsertraline hydrochloride	Sertraline hydrochloride 150 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-070	60290-0070-01
Sertraline HClsertraline hydrochloride	Sertraline hydrochloride 200 mg/1	CapsuleOral	Umedica Laboratories USA Inc.	60290-071	60290-0071-01
Sertraline HClsertraline	Sertraline hydrochloride 150 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-2789	69238-2789-01
Sertraline HClsertraline	Sertraline hydrochloride 200 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-2791	69238-2791-01
Sertraline HClsertraline hydrochloride	Sertraline hydrochloride 150 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-128	70377-0128-11
Sertraline HClsertraline hydrochloride	Sertraline hydrochloride 200 mg/1	CapsuleOral	Biocon Pharma Inc.	70377-129	70377-0129-11
sertraline HClsertraline hydrochloride	Sertraline hydrochloride 150 mg/1	CapsuleOral	Almatica Pharma LLC	52427-664	52427-0664-30
sertraline HClsertraline hydrochloride	Sertraline hydrochloride 200 mg/1	CapsuleOral	Almatica Pharma LLC	52427-672	52427-0672-30

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
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-611
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-612
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-613
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	QPharma Inc	42708-124
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	43353-447
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2071
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2080
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6379
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6613
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6614
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6861
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6917
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-173
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-265
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Quality Care Products LLC	55700-362
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-091
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-612
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-011
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-012
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0554

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