What is NDC 63187-453?

63187-453 is the product NDC for Olanzapine, Olanzapine 2.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 1 package NDC, 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 Olanzapine?

205 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Olanzapine NDC 63187-453 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0453Add 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
63187-453-30	6318704533063187045330	30 TABLET, FILM COATED in 1 BOTTLE (63187-453-30)Marketed from Feb 2, 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): Olanzapine
Generic name (nonproprietary): olanzapine
Active ingredients: Olanzapine — 2.5 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 090798
Marketing start: Apr 23, 2012
Listing expires: Dec 31, 2027
Identifiers: Product ID 63187-453_46cd719f-a6bc-4b3b-8ef5-860896fb787dSPL ID 46cd719f-a6bc-4b3b-8ef5-860896fb787dSPL set ID e40d54bf-7334-4418-8a87-ff85941adec1RxCUI 200034, 314154UNII N7U69T4SZR
Pharmacologic class: Atypical Antipsychotic

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

N463187045330 followed by a unit qualifier and the quantity

Package 63187-0453-30. 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 Jan 1, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine Tablets, USP are an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. ( 1.1 ) • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-453

What is NDC 63187-453?: 63187-453 is the product NDC for Olanzapine, Olanzapine 2.5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Olanzapine.
What is the active ingredient?: Olanzapine.
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 Olanzapine?: 205 other product NDCs are listed under this name. See all Olanzapine 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 Olanzapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0690	67046-0690-03
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4729	70518-4729-00
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6693	55154-6693-00
olanzapine	Olanzapine 15 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-563	69452-0563-13
olanzapine	Olanzapine 5 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-561	69452-0561-13
olanzapine	Olanzapine 10 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-562	69452-0562-13
olanzapine	Olanzapine 20 mg/1	Tablet, Orally disintegratingOral	Bionpharma Inc.	69452-564	69452-0564-13
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-061	87441-0061-01
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-062	87441-0062-01
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0072	67046-0072-03

All 206 Olanzapine NDCs

Other NDCs under ANDA 090798

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

FDA NDC Directory listings under ANDA 090798
Product	Strength	Form · route	Labeler	Product NDC
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6693
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-620
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-621
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-622
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-623
Olanzapine	Olanzapine 15 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-624
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	60429-625
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3110
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3111
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3112
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3113
Olanzapine	Olanzapine 15 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3114
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-3140
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-429
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-844
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0314
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3568
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2599
Olanzapine	Olanzapine 15 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-419
Olanzapine	Olanzapine 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-067