What is NDC 43598-164?

43598-164 is the product NDC for Olanzapine, Olanzapine 5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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 43598-164 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0164Add 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
43598-164-01	4359801640143598016401	100 TABLET, FILM COATED in 1 BOTTLE (43598-164-01)Marketed from Dec 10, 2013
43598-164-05	4359801640543598016405	500 TABLET, FILM COATED in 1 BOTTLE (43598-164-05)Marketed from Dec 10, 2013
43598-164-10	4359801641043598016410	1000 TABLET, FILM COATED in 1 BOTTLE (43598-164-10)Marketed from Dec 10, 2013
43598-164-30	4359801643043598016430	30 TABLET, FILM COATED in 1 BOTTLE (43598-164-30)Marketed from Dec 10, 2013
43598-164-78	4359801647843598016478	10 BLISTER PACK in 1 CARTON (43598-164-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (43598-164-79)Marketed from Dec 10, 2013

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076255
Marketing start: Dec 10, 2013
Listing expires: Dec 31, 2027
Identifiers: Product ID 43598-164_843a50ec-ce2a-cacd-ac2c-e4e6fca83ab9SPL ID 843a50ec-ce2a-cacd-ac2c-e4e6fca83ab9SPL set ID d474d5a9-d338-511d-5823-567c0a1bbf4dRxCUI 312078, 312079, 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

N443598016401 followed by a unit qualifier and the quantity

Package 43598-0164-01. 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 Mar 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Olanzapine is 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 ) Adolescents (ages 13 to 17): Efficacy was established in one 6week trial in patients with schizophrenia (14.1) . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1) • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: E…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-164

What is NDC 43598-164?: 43598-164 is the product NDC for Olanzapine, Olanzapine 5 mg/1 tablet, film coated, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 5 package NDCs, 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?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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 076255

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

FDA NDC Directory listings under ANDA 076255
Product	Strength	Form · route	Labeler	Product NDC
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-723
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-740
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-165
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Dr. Reddy's Laboratories Inc.	43598-166
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1611
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1605
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8722
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1635
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0110
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1764
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0714
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6881
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-6889
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-460
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-061
Olanzapine	Olanzapine 5 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-062
Olanzapine	Olanzapine 7.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0363
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2627
Olanzapine	Olanzapine 2.5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4012
Olanzapine	Olanzapine 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6376

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