ZYPREXA

Product NDC: 61269-640
11-digit product format: 612690640
Labeler code: 61269
Product ID: 61269-640_b23e8030-2d91-4970-b001-c13e5c94204b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR
Labeler: H2-Pharma LLC
Application: NDA021253
Marketing category: NDA
Marketing start: 2004-04-01
Substance: OLANZAPINE
Active strength: 10 mg/2mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
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 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021253-001	ZYPREXA	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021253-001	AP

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021253-001	ZYPREXA	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021253-001	ZYPREXA	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021253-001	ZYPREXA	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021253-001	ZYPREXA	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021253-001	ZYPREXA	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2004-03-29	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N021253-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021253-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021253-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021253-001	AP	1	`a50c72e98297…`

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: Intramuscular
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLANZAPINE	10 mg/2mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
42e9462d-db65-453b-8069-8fb2df9182e8	Product name	1	20211216
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
12d02c27-e8da-47f1-b815-ccca982731ef	Product name	9	20170802
877783eb-030c-6e3f-0979-804cf94d8856	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61269-640-20	ZYPREXA Intramuscular	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		68
61269-640-20	ZYPREXA Intramuscular	2 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	2		68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-640-20	EA - Each	61269-640	35650d19-df62-40a6-99fd-3b10651a83cf	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-640	ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [H2-PHARMA LLC]	66	Current NDC, 2 package rows	20250207_b418946a-1ab4-4d89-a012-d94fc361a3c4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N7U69T4SZR	OLANZAPINE	132539-06-1	OLANZAPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312076	OLANZapine 10 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
485968	OLANZapine 10 MG Injection	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
314154	OLANZapine 10 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
351107	OLANZapine 15 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312077	OLANZapine 15 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
200034	OLANZapine 2.5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
351108	OLANZapine 20 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
283639	OLANZapine 20 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
314155	OLANZapine 5 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312078	OLANZapine 5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312079	OLANZapine 7.5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
545353	ZyPREXA 10 MG Injection	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153048	ZyPREXA 10 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
261337	ZyPREXA 15 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
212405	ZyPREXA 2.5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
284514	ZyPREXA 20 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153046	ZyPREXA 5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153047	ZyPREXA 7.5 MG Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754503	ZyPREXA ZYDIS 10 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754504	ZyPREXA ZYDIS 15 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754505	ZyPREXA ZYDIS 20 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754506	ZyPREXA ZYDIS 5 MG Disintegrating Oral Tablet	PSN	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754503	olanzapine 10 MG Disintegrating Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
545353	olanzapine 10 MG Injection [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153048	olanzapine 10 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754504	olanzapine 15 MG Disintegrating Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
261337	olanzapine 15 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
212405	olanzapine 2.5 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754505	olanzapine 20 MG Disintegrating Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
284514	olanzapine 20 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754506	olanzapine 5 MG Disintegrating Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153046	olanzapine 5 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153047	olanzapine 7.5 MG Oral Tablet [Zyprexa]	SBD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312076	olanzapine 10 MG Disintegrating Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
485968	olanzapine 10 MG Injection	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
314154	olanzapine 10 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
351107	olanzapine 15 MG Disintegrating Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312077	olanzapine 15 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
200034	olanzapine 2.5 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
351108	olanzapine 20 MG Disintegrating Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
283639	olanzapine 20 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
314155	olanzapine 5 MG Disintegrating Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312078	olanzapine 5 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
312079	olanzapine 7.5 MG Oral Tablet	SCD	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
545353	Zyprexa 10 MG Injection	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153048	Zyprexa 10 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
261337	Zyprexa 15 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
212405	Zyprexa 2.5 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
284514	Zyprexa 20 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754506	Zyprexa 5 MG Disintegrating Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153046	Zyprexa 5 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
153047	Zyprexa 7.5 MG Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754503	Zyprexa Zydis 10 MG Disintegrating Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754504	Zyprexa Zydis 15 MG Disintegrating Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754505	Zyprexa Zydis 20 MG Disintegrating Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68
754506	Zyprexa Zydis 5 MG Disintegrating Oral Tablet	SY	b418946a-1ab4-4d89-a012-d94fc361a3c4	68

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61269-640-20	61269064020	1 VIAL in 1 CARTON (61269-640-20) / 2 mL in 1 VIAL	1 vial	2004-04-01	No	No	Current