What is NDC 63187-478?

63187-478 is the product NDC for Sertraline, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 63187. 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?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sertraline NDC 63187-478 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0478Add 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
63187-478-30	6318704783063187047830	30 TABLET, FILM COATED in 1 BOTTLE (63187-478-30)Marketed from May 1, 2015
63187-478-60	6318704786063187047860	60 TABLET, FILM COATED in 1 BOTTLE (63187-478-60)Marketed from May 1, 2015
63187-478-90	6318704789063187047890	90 TABLET, FILM COATED in 1 BOTTLE (63187-478-90)Marketed from May 1, 2015

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
Generic name (nonproprietary): sertraline
Active ingredients: Sertraline hydrochloride — 25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077670
Marketing start: Feb 6, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 63187-478_820641b5-c569-4a24-b0a4-5d17d3cff8eeSPL ID 820641b5-c569-4a24-b0a4-5d17d3cff8eeSPL set ID 35dea1a2-ec26-4e52-8f09-ee4678e77946RxCUI 312938, 312940, 312941UNII UTI8907Y6XUPC 0363187212308, 0363187055301, 0363187478902
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

N463187047830 followed by a unit qualifier and the quantity

Package 63187-0478-30. 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 Oct 1, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Major Depressive Disorder Sertraline tablets USP are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline tablets USP in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: c…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-478

What is NDC 63187-478?: 63187-478 is the product NDC for Sertraline, Sertraline hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sertraline.
What is the active ingredient?: Sertraline hydrochloride.
Who is the labeler?: Proficient Rx LP, NDC labeler code 63187. 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?: 31 other product NDCs are listed under this name. See all Sertraline 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4183	68788-4183-0168788-4183-0368788-4183-06+1 more
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-683	60760-0683-90
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4425	70518-4425-00
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8669	68788-8669-0168788-8669-0268788-8669-03+3 more
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-768	50268-0768-15
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-769	50268-0769-15
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-770	50268-0770-15
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-757	23155-0757-0323155-0757-0523155-0757-09
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-758	23155-0758-0323155-0758-0523155-0758-09+1 more
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-759	23155-0759-0323155-0759-0523155-0759-09

All 32 Sertraline NDCs

Other NDCs under ANDA 077670

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

FDA NDC Directory listings under ANDA 077670
Product	Strength	Form · route	Labeler	Product NDC
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5848
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7830
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8669
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4590
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7295
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4606
Sertraline	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-768
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-769
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-770
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-055
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1617
Sertraline	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3534
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	AvPAK	50268-823
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	AvPAK	50268-824
Sertraline Hydrochloride	Sertraline hydrochloride 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-825
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Quality Care Products, LLC	55700-225
Sertraline Hydrochloride	Sertraline hydrochloride 25 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-978
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4151
Sertraline	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0153
Sertraline Hydrochloride	Sertraline hydrochloride 50 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	68180-986

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