ZYPREXA

Product NDC: 61269-660
11-digit product format: 612690660
Labeler code: 61269
Product ID: 61269-660_9c56e9db-742e-4263-96b4-d92064f9baba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine pamoate
Dosage form: KIT
Route: INTRAMUSCULAR
Labeler: H2-Pharma LLC
Application: NDA022173
Marketing category: NDA
Marketing start: 2009-12-11
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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.

Additional Listing Data#

Finished product: Yes
Brand name base: ZYPREXA
Brand name suffix: Relprevv
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1718925	Internal RxNorm lookup
1718928	Internal RxNorm lookup
1718930	Internal RxNorm lookup
1718932	Internal RxNorm lookup
1718934	Internal RxNorm lookup
1718936	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
11544cba-64a9-49cb-8d74-da228053b252	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61269-660-20	ZYPREXARelprevv	1 in 1 CARTON	KIT	1		68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-660-20	EA - Each	61269-660	e298adfd-3a4c-4947-81e9-d76fe914483c	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-660	ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [H2-PHARMA LLC]	64	Current NDC, 1 package rows	20250207_11544cba-64a9-49cb-8d74-da228053b252.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 ndc (product): 61269-660

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1718934	OLANZapine 210 MG Extended Release Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718930	OLANZapine 300 MG Extended Release Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718925	OLANZapine 405 MG Extended Release Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718936	ZyPREXA Relprevv 210 MG Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718932	ZyPREXA Relprevv 300 MG Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718928	ZyPREXA Relprevv 405 MG Injection	PSN	11544cba-64a9-49cb-8d74-da228053b252	68
1718936	olanzapine 210 MG Injection [Zyprexa]	SBD	11544cba-64a9-49cb-8d74-da228053b252	68
1718932	olanzapine 300 MG Injection [Zyprexa]	SBD	11544cba-64a9-49cb-8d74-da228053b252	68
1718928	olanzapine 405 MG Injection [Zyprexa]	SBD	11544cba-64a9-49cb-8d74-da228053b252	68
1718934	olanzapine 210 MG Injection	SCD	11544cba-64a9-49cb-8d74-da228053b252	68
1718930	olanzapine 300 MG Injection	SCD	11544cba-64a9-49cb-8d74-da228053b252	68
1718925	olanzapine 405 MG Injection	SCD	11544cba-64a9-49cb-8d74-da228053b252	68
1718934	olanzapine 210 MG (as olanzapine pamoate monohydrate 483 MG) Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718930	olanzapine 300 MG (as olanzapine pamoate monohydrate 690 MG) Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718925	olanzapine 405 MG (as olanzapine pamoate monohydrate 931 MG) Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718936	Zyprexa 210 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718932	Zyprexa 300 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718928	Zyprexa 405 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718936	Zyprexa Relprevv 210 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718932	Zyprexa Relprevv 300 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68
1718928	Zyprexa Relprevv 405 MG Injection	SY	11544cba-64a9-49cb-8d74-da228053b252	68

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61269-660-20	61269066020	1 KIT in 1 CARTON (61269-660-20) * 1.4 mL in 1 VIAL * 3 mL in 1 VIAL	1 kit	2010-03-01	No	No	Current