Olanzapine

Product NDC: 0143-9199
11-digit product format: 001439199
Labeler code: 0143
Product ID: 0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olanzapine
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA218116
Marketing category: ANDA
Marketing start: 2025-09-18
Substance: OLANZAPINE
Active strength: 10 mg/2mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A218116-001	OLANZAPINE	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP		2025-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218116-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218116-001	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	2025-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218116-001	OLANZAPINE	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	2025-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218116-001	OLANZAPINE	10MG/VIAL	INJECTABLE / INTRAMUSCULAR	AP	2025-05-16	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218116-001	OLANZAPINE	10MG/VIAL	POWDER / INTRAMUSCULAR	AP	2025-05-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A218116-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218116-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218116-001	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218116-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olanzapine
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N7U69T4SZR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
485968	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
63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1	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
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
0143-9199-01	Olanzapine	2 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	2		2
0143-9199-01	Olanzapine	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9199-01	EA - Each	0143-9199	fd9ff8ed-0b8a-42f5-8a0c-87a393d24ce5	1	2025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olanzapine	OLANZAPINE	Hikma Pharmaceuticals USA Inc.	63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218116 application number: ANDA218116 ndc (product): 0143-9199
Olanzapine	OLANZAPINE	Qilu Pharmaceutical Co., Ltd.	12ce860a-6f22-4db6-8acf-786b40f5a5a5	2025-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218116 application number: ANDA218116

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0143-9199-01	00143919901	1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL	1 vial	2025-09-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olanzapine	Hikma Pharmaceuticals USA Inc. \| Qilu Pharmaceutical Co., Ltd. (Biological Industrial Park)	2026-06-03	HUMAN PRESCRIPTION DRUG LABEL	3