ondansetron

Product NDC: 67877-170
11-digit product format: 678770170
Labeler code: 67877
Product ID: 67877-170_e6bdf195-1cf2-4064-8432-45ffdb0d2b52
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ondansetron hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA077851
Marketing category: ANDA
Marketing start: 2007-06-25
Marketing end: 0000-00-00
Substance: ONDANSETRON HYDROCHLORIDE
Active strength: 8 mg/1
Pharmacologic classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67877-170-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67877-170-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67877-170-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67877-170-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67877-170-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67877-170-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67877-170-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67877-170-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67877-170-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67877-170-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67877-170-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67877-170-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67877-170-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67877-170-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67877-170-30	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077851-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB		2007-06-25
A077851-002	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB		2007-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A077851-001	AB
A077851-002	AB

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077851-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077851-002	ONDANSETRON HYDROCHLORIDE	EQ 8MG BASE	TABLET / ORAL	AB	2007-06-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077851-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077851-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077851-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077851-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077851-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077851-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077851-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077851-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077851-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077851-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077851-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077851-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077851-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077851-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077851-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077851-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077851-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077851-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077851-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077851-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077851-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077851-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077851-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077851-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077851-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077851-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077851-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077851-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077851-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ONDANSETRON HYDROCHLORIDE	8 mg/1

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
198052	Internal RxNorm lookup
312086	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
2edc0788-dc38-4d21-ba8e-71f159e2d3b1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67877-170-30	2024-01-30	C162847	48780-1	1030e365-4d73-111a-e063-dadaa90a10e2	2edc0788-dc38-4d21-ba8e-71f159e2d3b1
67877-170-30	2024-01-30	C162847	48780-1	1030e365-4d73-111a-e063-dadaa90a10e2	Ondansetron Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-170-30	ondansetron	30 in 1 BOTTLE	TABLET, FILM COATED	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-170-30	EA - Each	67877-170	4edc84be-e05f-48b4-99af-2da8d182fa54	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	8
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON HYDROCHLORIDE TABLET [KAISER FOUNDATION HOSPITALS]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS, INC.]	4
ONDANSETRON HYDROCHLORIDE	ACTIVE INGREDIENT	NMH84OZK2B	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
ONDANSETRON	ACTIVE MOIETY	4AF302ESOS	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-170	ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [ASCEND LABORATORIES, LLC]	9	Legacy NDC, 1 package rows	20190116_2edc0788-dc38-4d21-ba8e-71f159e2d3b1.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ondansetron	ONDANSETRON HYDROCHLORIDE	Ascend Laboratories, LLC	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851 ndc (product): 67877-170
Ondansetron	ONDANSETRON	REMEDYREPACK INC.	36592150-7e19-474c-9f96-cc8341e28b5d	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Golden State Medical Supply, Inc.	2b9ea1fc-59a4-8189-e063-6394a90a9ae6	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Natco Pharma USA LLC	64527de5-0b92-4340-9243-7a37e8ff96d9	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON	Bryant Ranch Prepack	f08f56de-8678-4da9-8cae-013a5c393453	2024-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
Ondansetron	ONDANSETRON TABLETS	Natco Pharma Limited	59c817b7-a1c6-48a5-9bfc-2c381532bfd9	2021-11-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ondansetron	ONDANSETRON HYDROCHLORIDE	Proficient Rx LP	bde7c22c-0047-4735-8df6-b48e8dfa478a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ONDANSETRON	ONDANSETRON	Proficient Rx LP	41c0dc3d-a616-425e-9073-625a0cb692c4	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ONDANSETRON	ONDANSETRON	Sun Pharmaceutical Industries, Inc.	834bc56a-657d-4733-9a60-47040cb5c7bf	2019-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851
ondansetron	ONDANSETRON HYDROCHLORIDE	Bryant Ranch Prepack	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	2019-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077851 application number: ANDA077851

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
198052	ondansetron HCl 4 MG Oral Tablet	PSN	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
312086	ondansetron HCl 8 MG Oral Tablet	PSN	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
198052	ondansetron 4 MG Oral Tablet	SCD	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
312086	ondansetron 8 MG Oral Tablet	SCD	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	2edc0788-dc38-4d21-ba8e-71f159e2d3b1	9
198052	ondansetron HCl 4 MG Oral Tablet	PSN	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
312086	ondansetron HCl 8 MG Oral Tablet	PSN	079fdfb4-8007-4f5a-a8fa-4b72c3748632	5
312086	ondansetron HCl 8 MG Oral Tablet	PSN	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
198052	ondansetron 4 MG Oral Tablet	SCD	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
312086	ondansetron 8 MG Oral Tablet	SCD	079fdfb4-8007-4f5a-a8fa-4b72c3748632	5
312086	ondansetron 8 MG Oral Tablet	SCD	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
198052	ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet	SY	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	079fdfb4-8007-4f5a-a8fa-4b72c3748632	5
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	37de0550-a6d1-46a8-a0b8-447b0dcf70ad	5
312086	ondansetron HCl 8 MG Oral Tablet	PSN	bde7c22c-0047-4735-8df6-b48e8dfa478a	3
312086	ondansetron 8 MG Oral Tablet	SCD	bde7c22c-0047-4735-8df6-b48e8dfa478a	3
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	bde7c22c-0047-4735-8df6-b48e8dfa478a	3
312086	ondansetron HCl 8 MG Oral Tablet	PSN	4722ff63-73f6-419e-b193-6af8bc701047	1
312086	ondansetron 8 MG Oral Tablet	SCD	4722ff63-73f6-419e-b193-6af8bc701047	1
312086	ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet	SY	4722ff63-73f6-419e-b193-6af8bc701047	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-170-30	67877017030	30 TABLET, FILM COATED in 1 BOTTLE (67877-170-30)	2007-06-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ondansetron - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-08-19	Human Prescription Drug Label	6
Ondansetron Tablets, USP	Ascend Laboratories, LLC	2026-07-22	Human Prescription Drug Label	11
ondansetron - RPK Pharmaceuticals, Inc.	RPK Pharmaceuticals, Inc.	2023-06-07	Human Prescription Drug Label	5
ondansetron - Proficient Rx LP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
ondansetron hydrochloride - Preferred Pharmaceuticals, Inc. \| Preferred Pharmaceuticals, Inc., Inc	Preferred Pharmaceuticals, Inc. \| Preferred Pharmaceuticals, Inc., Inc	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL	7
ondansetron - KAISER FOUNDATION HOSPITALS	KAISER FOUNDATION HOSPITALS	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	5
ondansetron - NuCare Pharmaceuticals,Inc.	NuCare Pharmaceuticals,Inc.	2018-08-15	HUMAN PRESCRIPTION DRUG LABEL	1
Ondansetron, USP	Aidarex Pharmaceuticals LLC	2017-05-24	HUMAN PRESCRIPTION DRUG LABEL	1