Ondansetron

Product NDC: 17856-0555
Requested package NDC: 17856-0555-2
11-digit product format: 178560555
Labeler code: 17856
Product ID: 17856-0555_f526ccd7-174f-4981-9417-64fc9a7b9eec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ondansetron Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA091342
Marketing category: ANDA
Marketing start: 2011-01-27
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-0555	17856-0555-2	D	Discontinued by firm		2026-08-10

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A091342-001	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA		2011-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091342-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091342-001	ONDANSETRON HYDROCHLORIDE	EQ 4MG BASE/5ML	SOLUTION / ORAL	AA	2011-01-27	`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	A091342-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091342-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091342-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091342-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091342-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091342-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091342-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091342-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091342-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091342-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091342-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091342-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091342-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091342-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091342-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091342-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091342-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091342-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091342-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091342-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091342-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091342-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091342-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091342-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091342-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091342-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091342-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091342-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091342-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091342-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091342-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091342-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091342-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091342-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091342-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091342-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091342-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091342-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091342-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091342-001	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
17856-0555-1	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-2	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-3	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-4	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-5	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-6	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-7	2024-05-09	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-1	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-2	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-3	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-4	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-5	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-6	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991
17856-0555-7	2023-01-30	These highlights do not include all the information needed to use ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP safely and effectively. See full prescribing information for ONDANSETRON HYDROCHLORIDE ORAL SOLUTION, USP. ONDANSETRON HYDROCHLORIDE solution, for oral use Initial U.S. Approval: 1991

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17856-0555-2	ML - Milliliter	17856-0555	94994d7d-5822-473f-bf3e-6808b3782c8d	1	2022-02-07
17856-0555-3	ML - Milliliter	17856-0555	c73dbb0f-27f7-412e-bb6a-1ed55d8b3497	1	2022-03-09

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	Chartwell Governmental & Specialty RX, LLC.	7e862601-1d8a-455b-8ce5-1a32478b309f	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091342 application number: ANDA091342
Ondansetron Hydrochloride	ONDANSETRON HYDROCHLORIDE	Chartwell RX, LLC.	2086bae8-7c3c-4663-93ac-c86407c524c2	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091342 application number: ANDA091342

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0555-2	17856055502	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0555-2) > 2.5 mL in 1 SYRINGE	120 syringe	2021-06-07	0000-00-00	No	No	Current