What is NDC 43602-981?

43602-981 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, listed with the FDA by Ascent Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Ascent Pharmaceuticals, Inc., NDC labeler code 43602. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sertraline Hydrochloride NDC 43602-981

NDC codes

FDA NDC Directory

Product NDC (as listed)43602-981Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43602-0981Add 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
43602-981-15	4360209811543602098115	30 TABLET in 1 BOTTLE (43602-981-15)Marketed from May 3, 2021
43602-981-16	4360209811643602098116	500 TABLET in 1 BOTTLE (43602-981-16)Marketed from May 3, 2021

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: Ascent Pharmaceuticals, Inc.NDC labeler code 43602
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214790
Marketing start: May 3, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 43602-981_91447af3-b3d6-4ffe-8c89-1869a22373baSPL ID 91447af3-b3d6-4ffe-8c89-1869a22373baSPL set ID 056191ca-999a-4c9b-93b9-64db44b8e628RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0343602464055, 0343602462051, 0343602463058, 0010100002194
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

N443602098115 followed by a unit qualifier and the quantity

Package 43602-0981-15. 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 10, 2021. 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 selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of: 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 43602-981

What is NDC 43602-981?: 43602-981 is the product NDC for Sertraline Hydrochloride, Sertraline hydrochloride 100 mg/1 tablet, listed with the FDA by Ascent Pharmaceuticals, Inc.. It has 2 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?: Ascent Pharmaceuticals, Inc., NDC labeler code 43602. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sertraline Hydrochloride	Sertraline hydrochloride 150 mg/1	Tablet, Film coatedOral	TRUPHARMA, LLC	52817-223	52817-0223-90
Sertraline Hydrochloride	Sertraline hydrochloride 200 mg/1	Tablet, Film coatedOral	TRUPHARMA, LLC	52817-224	52817-0224-90
Sertraline hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4707	70518-4707-0070518-4707-02
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4151	68788-4151-0168788-4151-0368788-4151-06+1 more
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1181	67046-1181-03
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-076	87441-0076-01
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-077	87441-0077-01
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-075	87441-0075-01
Sertraline hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1682	67046-1682-03
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0555	67046-0555-03

All 183 Sertraline Hydrochloride NDCs

Other NDCs under ANDA 214790

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

FDA NDC Directory listings under ANDA 214790
Product	Strength	Form · route	Labeler	Product NDC
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	TabletOral	A-S Medication Solutions	50090-7693
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	TabletOral	A-S Medication Solutions	50090-7694
Finjozysertraline hydrochloride	Sertraline hydrochloride 75 mg/1	TabletOral	Method Pharmaceuticals LLC	58657-275
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	Ascent Pharmaceuticals, Inc.	43602-979
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	TabletOral	Ascent Pharmaceuticals, Inc.	43602-980
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	TabletOral	A-S Medication Solutions	50090-7692
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	TabletOral	A-S Medication Solutions	50090-7691
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-205
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-206
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-207
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3951
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-145
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-146
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-147