ondansetron

Product NDC: 25021-777
11-digit product format: 250210777
Labeler code: 25021
Product ID: 25021-777_dbbafc2b-987e-421b-bcfc-d4706859420e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA079224
Marketing category: ANDA
Marketing start: 2012-08-30
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: 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
A079224-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP		2009-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079224-001	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	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079224-001	ONDANSETRON HYDROCHLORIDE	EQ 2MG BASE/ML	INJECTABLE / INJECTION	AP	2009-09-25	`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	A079224-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079224-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079224-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079224-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079224-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079224-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079224-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079224-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079224-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079224-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079224-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079224-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079224-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079224-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079224-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079224-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079224-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079224-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079224-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079224-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079224-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079224-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079224-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079224-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079224-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079224-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079224-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079224-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079224-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079224-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079224-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079224-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079224-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079224-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079224-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079224-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079224-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079224-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079224-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079224-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ondansetron
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	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
25021-777-02	ondansetron	2 mL in 1 VIAL	INJECTION, SOLUTION	2		12
25021-777-02	ondansetron	25 in 1 CARTON	INJECTION, SOLUTION	25		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-777-02	ML - Milliliter	25021-777	6aa330b0-c341-4568-beab-4326c50a5b1f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ondansetron hydrochloride	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
ondansetron	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5
water	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25021-777	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	12	Current NDC, Legacy NDC, 2 package rows	20240918_ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b746d4db-43e6-4219-9e6b-f53e59581305	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
Ondansetron	ONDANSETRON	Fosun Pharma USA Inc.	e3f22b7e-b6ad-4799-93c7-d30540cada85	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
Ondansetron	ONDANSETRON	Gland Pharma Limited	3efa5604-96c3-42a0-8e99-b3de4a66aa92	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224
ondansetron	ONDANSETRON HYDROCHLORIDE	Sagent Pharmaceuticals	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224 ndc (product): 25021-777
ONDANSETRON	ONDANSETRON	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	8cea2f3a-cfa5-4a68-9ff4-b5a5a2085d08	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079224 application number: ANDA079224

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NMH84OZK2B	ONDANSETRON HYDROCHLORIDE	103639-04-9	ONDANSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1740467	ondansetron 4 MG in 2 ML Injection	PSN	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	12
1740467	2 ML ondansetron 2 MG/ML Injection	SCD	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	12
1740467	ondansetron 4 MG per 2 ML Injection	SY	ba0f8f13-1f7d-44e0-9c0f-0b43a9e8e3a7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-777-02	25021077702	25 VIAL in 1 CARTON (25021-777-02) / 2 mL in 1 VIAL	25 vial	2012-08-30	0000-00-00	No	No	Current