Ondansetron

Product NDC: 0641-6079
Requested package NDC: 0641-6079-01
11-digit product format: 006416079
Labeler code: 0641
Product ID: 0641-6079_9e948e67-37a3-48ca-ae91-a73efea950aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA077365
Marketing category: ANDA
Marketing start: 2006-12-26
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 2 mg/mL
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [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 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
A077365-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2006-12-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077365-001	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 · 41 observed 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	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077365-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2006-12-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077365-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077365-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077365-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077365-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077365-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077365-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077365-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077365-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077365-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077365-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077365-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077365-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077365-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077365-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077365-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077365-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077365-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077365-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077365-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077365-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077365-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077365-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077365-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077365-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077365-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077365-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077365-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077365-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077365-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077365-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077365-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077365-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077365-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077365-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077365-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077365-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077365-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077365-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077365-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077365-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NMH84OZK2B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283504	Internal RxNorm lookup
1740467	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
c29ca6df-621d-44b6-98fc-b48666573366	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9bd4853-037c-6968-f4d4-9bb9a0efd1ea	Product name	2	20250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6079-01	Ondansetron	20 mL in 1 CARTON	INJECTION	20		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6079-01	ML - Milliliter	0641-6079	0dc5eac6-db16-490a-a3ef-13d6331810dd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6079	ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 1 package rows	20240411_c29ca6df-621d-44b6-98fc-b48666573366.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	97713356-f42b-4a67-95f6-561afa68c0c2	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077365 application number: ANDA077365
Ondansetron	ONDANSETRON	Hikma Pharmaceuticals USA Inc.	c29ca6df-621d-44b6-98fc-b48666573366	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077365 application number: ANDA077365 ndc (package): 0641-6079-01 ndc (product): 0641-6079 ndc11 (package): 00641607901

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE
4AF302ESOS	ONDANSETRON	99614-02-5	Ondansetron

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283504	ondansetron 2 MG/ML Injectable Solution	PSN	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	ondansetron 4 MG in 2 ML Injection	PSN	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	c29ca6df-621d-44b6-98fc-b48666573366	17
283504	ondansetron 2 MG/ML Injectable Solution	SCD	c29ca6df-621d-44b6-98fc-b48666573366	17
283504	ondansetron (as ondansetron HCl ) 2 MG/ML Injectable Solution	SY	c29ca6df-621d-44b6-98fc-b48666573366	17
1740467	ondansetron 4 MG per 2 ML Injection	SY	c29ca6df-621d-44b6-98fc-b48666573366	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6079-01	00641607901	20 mL in 1 CARTON (0641-6079-01)	20 ml	2006-12-26	0000-00-00	No	No	Current