Ondansetron Hydrochloride

Product NDC: 68094-763
11-digit product format: 680940763
Labeler code: 68094
Product ID: 68094-763_058d49ad-8056-4e04-9b29-3e088d9b86d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Precision Dose Inc.
Application: ANDA076960
Marketing category: ANDA
Marketing start: 2015-02-27
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 4 mg/5mL
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
A076960-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	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
A076960-001	AA

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	RS	2006-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2006-12-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076960-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		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	A076960-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076960-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076960-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076960-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076960-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076960-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076960-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076960-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076960-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076960-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076960-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076960-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076960-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076960-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076960-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076960-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076960-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076960-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076960-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076960-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076960-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076960-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076960-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076960-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076960-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076960-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076960-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076960-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076960-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076960-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076960-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076960-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076960-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076960-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076960-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076960-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076960-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076960-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076960-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076960-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	4 mg/5mL

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
312085	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
04800a86-2391-44e6-8763-d65e8a916c26	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
32e23bc9-ce14-4555-bb6d-bcb654d7d296	Product name	1	20201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49	Product name	1	20201015
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
909480fe-0d18-c1c1-a658-0bd9a7131822	Product name	5	20170829
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68094-763-59	Ondansetron Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	5
68094-763-62	Ondansetron Hydrochloride	3 in 1 CASE	SOLUTION	3	5
68094-763-62	Ondansetron Hydrochloride	10 in 1 TRAY	SOLUTION	10	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-763-59	ML - Milliliter	68094-763	950128e8-e767-4a20-a176-b9c71848e22a	1	2015-04-03
68094-763-62	ML - Milliliter	68094-763	e2f30011-bb76-490c-8c5e-609d6f8d6720	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ondansetron Hydrochloride	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
Ondansetron	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
saccharin sodium anhydrous	INACTIVE INGREDIENT	I4807BK602	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-763	ONDANSETRON HYDROCHLORIDE SOLUTION [PRECISION DOSE INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240316_04800a86-2391-44e6-8763-d65e8a916c26.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 Hydrochloride	ONDANSETRON HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	1a0c4dc6-643e-4ee7-92a9-edb98049a5ba	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076960 application number: ANDA076960
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Precision Dose Inc.	04800a86-2391-44e6-8763-d65e8a916c26	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076960 application number: ANDA076960 ndc (product): 68094-763

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
312085	ondansetron HCl 4 MG in 5 mL Oral Solution	PSN	04800a86-2391-44e6-8763-d65e8a916c26	5
312085	ondansetron 0.8 MG/ML Oral Solution	SCD	04800a86-2391-44e6-8763-d65e8a916c26	5
312085	ondansetron (as ondansetron HCl dihydrate) 4 MG per 5 ML Oral Solution	SY	04800a86-2391-44e6-8763-d65e8a916c26	5
312085	ondansetron 4 MG per 5 ML Oral Solution	SY	04800a86-2391-44e6-8763-d65e8a916c26	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-763-59	68094076359	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
68094-763-62	68094076362	3 TRAY in 1 CASE (68094-763-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-763-59)	3 tray	2015-02-27	0000-00-00	No	No	Current