ZYPREXA

Product NDC: 0002-7635
11-digit product format: 000027635
Labeler code: 0002
Product ID: 0002-7635_0a5b6cfe-5486-4622-a362-f1afd9bd8f56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine pamoate
Dosage form: KIT
Route: INTRAMUSCULAR
Labeler: Eli Lilly and Company
Application: NDA022173
Marketing category: NDA
Marketing start: 2009-12-11
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0002-7635		D	Discontinued by firm		2026-10-05
excluded package	package	0002-7635	0002-7635-11	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022173-001	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11
N022173-002	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11
N022173-003	ZYPREXA RELPREVV	OLANZAPINE PAMOATE	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-002	ZYPREXA RELPREVV	EQ 300MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022173-003	ZYPREXA RELPREVV	EQ 405MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022173-001	ZYPREXA RELPREVV	EQ 210MG BASE/VIAL	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2009-12-11	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0002-7635-11	EA - Each	0002-7635	5053af3b-aca1-4b33-8e07-09aa806183e6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Olanzapine pamoate	ACTIVE INGREDIENT	X7S6Q4MHCB	ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [ELI LILLY AND COMPANY]	45
Olanzapine	ACTIVE MOIETY	N7U69T4SZR	ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [ELI LILLY AND COMPANY]	45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0002-7635	ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [ELI LILLY AND COMPANY]	64	Legacy NDC	20250110_f9a73185-88de-4d7b-b3c0-bbf231483241.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZYPREXA Relprevv	OLANZAPINE PAMOATE	H2-Pharma LLC	11544cba-64a9-49cb-8d74-da228053b252	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022173 application number: NDA022173

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X7S6Q4MHCB	OLANZAPINE PAMOATE	221373-18-8	Olanzapine pamoate

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0002-7635-11	00002763511	1 KIT in 1 CARTON (0002-7635-11) * 1.4 mL in 1 VIAL (0002-7658-01) * 3 mL in 1 VIAL (0002-7622-01)	1 kit	2010-03-01	0000-00-00	No	No	Current